Tissue augmentation scaffolds for use with soft tissue fixation repair systems and methods

ABSTRACT

Devices, systems, and methods to improve both the reliability of soft tissue repair procedures and the speed at which the procedures are completed are provided. The devices and systems include one or more tissue augmentation constructs, which include constructs that are configured to increase a footprint across which suture applied force to tissue when the suture is tied down onto the tissue. The tissue augmentation constructs can be quickly and easily associated with the repair suture, and can be useful in many different tissue repair procedures that are disclosed in the application. In one exemplary embodiment, one or more constructs are disposed on a suture threader, which can be used to associate the construct(s) with a repair suture(s) being used to repair the soft tissue. Tissue augmentation constructs can include various blocks and patches, among other formations. Exemplary methods for manufacturing the tissue augmentation constructs are also provided.

CROSS REFERENCE TO RELATED APPLICATIONS

The present application claims priority to U.S. Provisional PatentApplication Ser. No. 62/289,702, filed Feb. 1, 2016, and entitled“COMPRESSION STRIPS AND SCAFFOLDS FOR USE IN SOFT TISSUE FIXATION,” U.S.Provisional Patent Application Ser. No. 62/348,548, filed Jun. 10, 2016,and entitled “COMPRESSION CONSTRUCTS AND RELATED METHODS FOR USE IN SOFTTISSUE FIXATION,” and U.S. Provisional Patent Application Ser. No.62/393,277, filed Sep. 12, 2016, and entitled “TISSUE AUGMENTATIONCONSTRUCTS AND RELATED METHODS FOR USE IN SOFT TISSUE FIXATION,” all ofwhich are incorporated by reference herein in their entireties.

FIELD

The present disclosure relates to systems, devices, and methods forsecuring soft tissue to bone, and more particularly relates to systems,devices, and methods that increase the area of coverage and/orcompression between suture filament and tissue during procedures likerotator cuff repairs.

BACKGROUND

A common injury, especially among athletes and people of advancing age,is the complete or partial detachment of tendons, ligaments, or othersoft tissues from bone. Tissue detachment may occur during a fall, byoverexertion, or for a variety of other reasons. Surgical interventionis often needed, particularly when tissue is completely detached fromits associated bone. Currently available devices for tissue attachmentinclude screws, staples, suture anchors, and tacks. Currently availabledevices for patients of advancing age can be particularly insufficientdue to degenerated tissue leading to inadequate suture-to-anchorfixation and further damage to the soft tissue.

Repair constructs made from one or more surgical filaments are typicallyused in soft tissue repair procedures, e.g., rotator cuff fixations, tosecure the tissue in a desired location. The repair constructs aretypically disposed through one or more portions of the tissue to berepaired, which can cause trauma to the tissue, and are often coupled toanchors disposed in bone to which the tissue is to be approximated.Further, in situations where the soft tissue has already begun todegenerate, the added pressure applied by the sutures can cause furtherdamage to the tissue, for instance by causing abrasion of the tissue or“cheese-wiring,” which refers to one or more strings of tissue peelingaway from the main tissue like a string of cheese peels away from acheese block when a wire cheese slicer is used to separate cheese fromthe block. In other words, because the suture has a small surface area,and a significant amount of force is being applied to the soft tissueover the small surface area of the tissue, the suture may have atendency to cut into the already compromised tissue, thus causingfurther damage. Currently available solutions to this problem includethe application of a relatively large formation of allograft orxenograft, typically about 3 centimeters by about 3 centimeters, to thesoft tissue after the repair has been performed but prior to tighteningthe soft tissue down with the suture. The application of the formation,however, is often expensive, necessitates many sutures, and requires ahigh skill level to operate and is thus used by only a select fewsurgeons. Further, the application of the relatively large formation canadd a significant amount of time to a surgical procedure, on the orderof an additional half hour to one hour per allograft or xenograftformation applied.

It is therefore desirable to provide systems, devices, and methods foruse in soft tissue repair that are robust, strong, and promote healing,yet minimize the costs and time of the procedure.

SUMMARY

Systems, devices, and methods are generally provided for performingsurgical procedures involving sutures, such as rotator cuff repairs,among other suture repair procedures. More specifically, the systems,devices, and methods are designed to allow a user to quickly add one ormore tissue augmentation constructs or matrices onto suture being usedto perform the tissue repair. The tissue augmentation constructs, whichcome in a variety of configurations, including but not limited to tapes,tubes, blocks, rings, tacks, washers, and patches, can expand afootprint of the sutures with which they are associated. The expandedfootprint helps distribute force applied by the suture on the tissueacross a greater surface area, can protect aspects of the system and/ortissue, provide bulk to otherwise compromised or degenerate tissueand/or tendon, and can help promote tissue growth and repair at thesurgical site.

The tissue augmentation constructs can be associated with the suture(s)in an on-demand fashion so that a surgeon can quickly and easily expandthe footprint of the sutures, or similarly purposed materials such assuture tape, being used based on the needs presented during theprocedure. The constructs can be associated with suture using a varietyof techniques, including disposing the constructs on the suture andthreading the suture through the constructs, among other techniques. Insome exemplary embodiments, a tissue augmentation construct ispredisposed on a threader, and the threader is operable to associate asuture being used in the soft tissue repair with the tissue augmentationconstruct. Surgical procedures that utilize the tissue augmentationconstructs provided for in the present disclosure are also provided, asare various manufacturing techniques and methods for forming tissueaugmentation constructs.

In one exemplary embodiment, a surgical soft tissue repair systemincludes a first suture limb and a first tissue augmentation block. Thetissue augmentation block is disposed on the first suture limb such thatthe first tissue augmentation block extends along a first length of thefirst suture limb. As a result, a tissue engaging surface area of thesystem along the first length is increased. The system can additionallyinclude a second suture limb and a second tissue augmentation block. Thesecond tissue augmentation block can be disposed on the second suturelimb such that the second tissue augmentation block extends along asecond length of the second suture limb. The second tissue augmentationblock can further increase a second tissue engaging surface area of thesystem along the second length. The first suture limb and the secondsuture limb can be formed from a single suture. Alternatively, the firstsuture limb and the second suture limb can be formed from differentsutures.

The first tissue augmentation block can have a number of differentconfigurations. In one configuration, the first tissue augmentationblock includes an opening that extends through the first tissueaugmentation block with the first suture limb being disposed through theopening of the first tissue augmentation block such that the firsttissue augmentation block freely passes along a length of the firstsuture limb in an unrestricted manner. In a second configuration, thefirst tissue augmentation block includes a tape having a substantiallyflat tissue-engaging surface with a width that is at least two times aslarge as a diameter of the first suture limb and a length that issubstantially greater than the width of the tape. The first suture limbon which the tape is disposed extends through the substantially flattissue-engaging surface of the tape at a plurality of locations alongthe length of the substantially flat tissue-engaging surface. Otherconfigurations of tissue augmentation blocks are also provided for,including but not limited to bars and washers. In configurations wherethe system includes first and second tissue augmentation blocks, thefirst and second tissue augmentation blocks can have the same ordifferent configurations. Further, in some embodiments, the first tissueaugmentation block can include at least one of: fabric, plastic,synthetic polymer, natural polymer, collagen, collagen scaffold,reconstituted collagen, a biological autograft, allograft, allogenic,xenogeneic, or xenograft, connective tissue including human dermalmatrix, acellular porcine dermal matrix, acellular bovine dermal matrix,periosteal tissue, pericardial tissue, and/or fascia, and combinationsthereof. In some embodiments, the first tissue augmentation blockincludes collagen. The blocks can be woven, non-woven, knitted, ormanufactured using a variety of techniques known to those skill in theart or otherwise provided for herein.

In some embodiments, at least one additional tissue augmentation blockcan be disposed on the first suture limb. For example, each of anadditional tissue augmentation block of the at least one additionaltissue augmentation block and the first tissue augmentation blockdisposed on the first suture limb can include a washer. The washer canhave an opening that extends through a thickness of the washer, and thefirst suture limb on which the washer is disposed can extend through thewasher opening. The washer can be sized such that the thickness of thewasher is substantially less than a length of the first suture limb onwhich the washer is disposed.

The system can also include a threader on which the first tissueaugmentation block is disposed. The threader can include a distal endthat is configured to receive the first suture limb and dispose thefirst tissue augmentation block onto the first suture limb as thethreader is moved with respect to the first tissue augmentation block.The threader can more specifically include a collapsible opening at thedistal end that is configured to receive the first suture limb, aproximal handle portion, and an elongate intermediate portion thatextends between the collapsible opening and the proximal handle portion.The elongate intermediate portion can have the first tissue augmentationblock disposed on it. The threader can be configured such that applyinga force to the proximal handle portion advances the elongateintermediate portion and the collapsible opening in the direction of theapplied force such that when the first suture limb is disposed withinthe collapsible opening, the applied force disposes the first tissueaugmentation block onto the first suture limb. The system can furtherinclude an installation tool that has a handle portion and a cartridge.The cartridge can have a length and a width that is sized to receive andretain the first tissue augmentation block disposed on the threader,with the threader extending through the entire length of the cartridge.

In another exemplary embodiment, a soft tissue suture repair systemincludes a tissue augmentation block and a threader. The threader has aproximal handle, a distal receiving end, and an intermediate portionextending between the proximal handle and the distal receiving end. Theintermediate portion of the threader has the tissue augmentation blockdisposed on it. Further, the threader is configured to dispose thetissue augmentation block onto a suture by associating a suture with thedistal receiving end and applying a force to the proximal handle toadvance the distal receiving end towards the tissue augmentation block.

In some embodiments the threader can be configured such that the distalreceiving end, and thus a suture associated therewith, passes throughthe tissue augmentation block in response to the application of theforce to the proximal handle. Sometimes, the intermediate portion is afilament portion, a fiber, a thread, a wire, a cord, and/or some otherflexible structure. Further, the system can include a suture that can beconfigured to be associated with the distal receiving end of thethreader and can be configured to have the tissue augmentation blockdisposed on it.

The tissue augmentation block can have various configurations. In oneconfiguration, the tissue augmentation block includes an opening thatextends through the block and the intermediate portion of the threadercan be disposed through the opening. In a second configuration, thetissue augmentation block includes a tape having a substantially flattissue-engaging surface with a width that is at least two times as largeas a diameter of the suture on which the tape is disposed, and a lengththat is substantially greater than the width of the tape. Theintermediate portion of the threader on which the tape is disposed canextend through the substantially flat tissue-engaging surface of thetape at a plurality of locations along the length of the substantiallyflat tissue-engaging surface. Other configurations are also providedfor, including but not limited to the tissue augmentation blockincluding a bar or a washer.

The system can include an installation tool for disposing the tissueaugmentation block on a suture. The installation tool can include ahandle portion and a cartridge. The cartridge can have a length and awidth that is sized to receive and retain the tissue augmentation block.Further, in some embodiments, the tissue augmentation block can includeat least one of: fabric, plastic, synthetic polymer, natural polymer,collagen, collagen scaffold, reconstituted collagen, biologicalautograft connective tissue, biological allograft connective tissue,biological xenograft connective tissue, human dermal matrix, porcinedermal matrix, bovine dermal matrix, periosteal tissue, pericardialtissue, and fascia, and in some embodiments, the tissue augmentationblock include collagen.

In still another exemplary embodiment, a surgical kit for soft tissuerepair includes one or more bone anchors, one or more sutures, one ormore tissue augmentation blocks, and one or more threaders. Each tissueaugmentation block is configured to be disposed on a suture limb of asuture of the one or more sutures. Further, at least one of thethreaders is configured to dispose a tissue augmentation block of theone or more tissue augmentation blocks onto a suture of the one or moresutures.

In some embodiments the surgical kit can also include a drill fordrilling a bone hole sized to receive a bone anchor of the one or morebone anchors. In various embodiments, the one or more tissueaugmentation blocks can include a plurality of tissue augmentationblocks, and/or the one or more sutures can include a plurality ofsutures, and/or the one or more bone anchors can include a plurality ofbone anchors.

One of the one or more tissue augmentation blocks can include an openingextending through the block. The opening can be configured to have thesuture limb extending through the tissue augmentation block when thetissue augmentation block is disposed on the suture limb such that thetissue augmentation block freely passes along a length of the suturelimb in an unrestricted manner. Alternatively, one of the one or moretissue augmentation blocks can include a tape having a substantiallyflat tissue-engaging surface with a width that is at least two times aslarge as a diameter of the suture limb on which the tissue augmentationblock is disposed and a length that is substantially greater than thewidth of the tape. The substantially flat tissue-engaging surface can beconfigured to have the suture limb extend through it at a plurality oflocations along the length of the substantially flat tissue-engagingsurface when the tissue augmentation block is disposed on the suturelimb. Other configurations of the one or more tissue augmentation blocksare also provided for, including but not limited to bars and washers.The washers can be sized such that a thickness of the washer issubstantially less than a length of a suture limb on which the washer isto be disposed. Further, in some embodiments, a tissue augmentationblock of the one or more tissue augmentation blocks can include at leastone of: fabric, plastic, synthetic polymer, natural polymer, collagen,collagen scaffold, reconstituted collagen, a biological autograft,allograft, allogenic, xenogeneic, or xenograft, connective tissueincluding human dermal matrix, acellular porcine dermal matrix,acellular bovine dermal matrix, periosteal tissue, pericardial tissue,and/or fascia, and combinations thereof. In some embodiments, one orboth of the first and second augmentation blocks includes collagen. Theblocks can be woven, non-woven, knitted, or manufactured using a varietyof techniques known to those skill in the art or otherwise provided forherein.

One or more of the threaders can include a proximal handle, a distalreceiving end, and an intermediate portion extending between theproximal handle and the distal receiving end. The threader can beconfigured to dispose one or more tissue augmentation blocks onto one ormore sutures by associating one or more sutures with the distalreceiving end and applying a force to the proximal handle to advance thedistal receiving end towards the one or more tissue augmentation blocks.The distal receiving end can be configured such that the distalreceiving end, and thus one or more sutures associated therewith, passesthrough one or more tissue augmentation blocks in response to theapplication of the force to the proximal handle.

In an exemplary method of soft tissue repair, the method includesattaching a first suture to soft tissue such that two suture limbs ofthe first suture extend from the soft tissue, disposing at least onetissue augmentation block on at least one of the first and second suturelimbs, coupling the two suture limbs with at least one suture anchordisposed in bone, and tightening the suture limbs such that the tissueaugmentation block(s) is directed towards the soft tissue. By disposinga tissue augmentation block on at least one of the two suture limbs, asurface area for engaging tissue associated with the respective suturelimb is increased. One or more tissue augmentation blocks can bedisposed on both suture limbs if desired.

In some embodiments the step of attaching a first suture to soft tissuesuch that two suture limbs of the suture extend from the soft tissuefurther comprises installing a medial row stitch. In such embodiments,the step of coupling the two suture limbs with at least one sutureanchor disposed in bone can include installing a lateral row fixation.

In some embodiments the step of disposing at least one tissueaugmentation block on at least one of the first and second limbs caninclude coupling a first limb of the two suture limbs to a threaderassociated with a first tissue augmentation block and applying a forceto the threader associated with the first tissue augmentation block todispose the first tissue augmentation block on the first limb. Themethod can further include coupling a second limb of the two suturelimbs to a threader associated with a second tissue augmentation blockand applying a force to the threader associated with the second tissueaugmentation block on the second limb.

The tissue augmentation block(s) used in the methods can have a varietyof configurations. For example, in some instances, one or more of thetissue augmentation blocks can include an opening extending through theblock, and the opening can be configured to have one of the suture limbsextending therethrough when the tissue augmentation block is disposed onthe respective suture limb such that the tissue augmentation blockfreely passes along a length of the suture limb in an unrestrictedmanner. By way of further non-limiting example, in some instances, oneor more of the tissue augmentation blocks can include a tape having asubstantially flat tissue-engaging surface with a width that is at leasttwo times greater than a diameter of the suture limb on which the blockis disposed, and a length that is substantially greater than the widthof the tape. The substantially flat tissue-engaging surface can beconfigured to have the suture limb extend through it at a plurality oflocations along the length of the substantially flat tissue-engagingsurface when the tissue augmentation block is disposed on the suturelimb. Other configurations of tissue augmentation blocks are alsoprovided for, including but not limited to bars and washers. The washerscan be sized such that a thickness of the washer is substantially lessthan a length of a suture limb on which the washer is to be disposed.Further, in some embodiments, one or more of the tissue augmentationblocks can include at least one of: fabric, plastic, synthetic polymer,natural polymer, collagen, collagen scaffold, reconstituted collagen, abiological autograft, allograft, allogenic, xenogeneic, or xenograft,connective tissue including human dermal matrix, acellular porcinedermal matrix, acellular bovine dermal matrix, periosteal tissue,pericardial tissue, and/or fascia, and combinations thereof. In someembodiments, one or both of the first and second augmentation blocksincludes collagen. The blocks can be woven, non-woven, knitted, ormanufactured using a variety of techniques known to those skill in theart or otherwise provided for herein.

In some embodiments that include a second suture, the step of couplingthe two suture limbs with at least one suture anchor disposed in bonecan include coupling the two suture limbs with a first suture anchor ofthe at least one suture anchor. The method can additionally includeattaching a second suture to the soft tissue such that a third suturelimb and a fourth suture limb extend from the soft tissue. At least onesecond tissue augmentation block can be can be disposed on at least oneof the third and fourth suture limbs, and the third and fourth suturelimbs can be coupled with a second anchor of the at least one sutureanchor disposed in bone. The method can further include tightening thethird and fourth suture limbs such that the second tissue augmentationblock is directed towards the soft tissue. By disposing a tissueaugmentation block on at least one of the third and fourth suture limbs,a surface area for engaging tissue associated with at least one of thethird and fourth suture limbs is increased. One or more tissueaugmentation blocks can be disposed on both suture limbs if desired.

The step of disposing at least one tissue augmentation block on at leastone of the first and second suture limbs can include disposing a firsttissue augmentation block on the first suture limb and a second tissueaugmentation block on the second suture limb in some instances. In someof those instances, the first and second suture limbs can be coupledtogether to form a mattress stitch.

In yet other embodiments the method can further include attaching asecond suture to the soft tissue such that a third suture limb and afourth suture limb extend from the soft tissue, disposing at least onesecond tissue augmentation block on at least one of the third and fourthsuture limbs, and disposing at least one tissue augmentation block oneach of the first and second suture limbs of the first suture. Bydisposing tissue augmentation blocks on the first, second, and at leastone of the third and fourth suture limbs, a surface area for engagingtissue associated with the respective suture limbs are increased. Themethod can further include coupling the first and third suture limbswith a first suture anchor disposed in the bone, and coupling the secondand fourth suture limbs with a second suture anchor disposed in thebone. In some embodiments, the second and third limbs can cross overeach other. The method can further include tightening the first, second,third, and fourth suture limbs such that the tissue augmentation blocksare directed towards the soft tissue.

In still other embodiments, the method can further include attaching asecond suture to the soft tissue such that a third suture limb and afourth suture limb extend from the soft tissue. The first and secondlimbs of the first suture can be coupled together, for instance by usinga first knot to tie them together. The at least one tissue augmentationblock that is disposed on at least one of the first and second suturelimbs can be slid over the first knot. The third and fourth suture limbsalso can be coupled together, for instance by using a second knot to tiethem together. At least one of the third and fourth suture limbs canextend above the at least one tissue augmentation block to help maintaina location of the at least one tissue augmentation block with respect tothe soft tissue.

Sometimes the method can include attaching a second suture to the softtissue at a location that is laterally displaced from a location of thefirst suture such that a third suture limb and a fourth suture limbextend from the soft tissue. Further, a tissue augmentation block of theat least one tissue augmentation block can be disposed on the firstsuture limb. The first and third suture limbs can be coupled together toform a mattress stitch, for instance by using a first knot to tie themtogether, and the tissue augmentation block of the at least one tissueaugmentation block can be slid over the first knot. The second andfourth suture limbs also can be coupled together, for instance by usinga second knot to tie them together. At least one of the second andfourth suture limbs can extend above the tissue augmentation block tohelp maintain a location of the tissue augmentation block with respectto the soft tissue.

In other embodiments, the first tissue augmentation block of the atleast one tissue augmentation block can be disposed on the first suturelimb. In some such embodiments, the method can include attaching asecond suture to the soft tissue such that a third suture limb and afourth suture limb extend from the soft tissue. A second tissueaugmentation block of the at least one tissue augmentation block can bedisposed on the fourth suture limb, thereby increasing a surface areafor engaging tissue associated with the fourth suture limb. Further, athird tissue augmentation block of the at least one tissue augmentationblock can be disposed on each of the second and third suture limbs. Thefirst and second suture limbs can be coupled with a first suture anchordisposed in the bone, and the third and fourth suture limbs can becoupled with a second suture anchor disposed in the bone. The first,second, third, and fourth suture limbs can be tightened such that thefirst, second, and third tissue augmentation blocks can be directedtowards the soft tissue.

Another exemplary method of soft tissue repair includes coupling a firstsuture limb of a first suture to a first threader having a first tissueaugmentation block disposed thereon, the first suture being attached toa first suture implant disposed in bone in a body, and the first suturelimb being coupled to tissue, and applying a force to the first threaderto move the first threader with respect to the first tissue augmentationblock such that the first suture limb is passed into the first tissueaugmentation block to dispose the first tissue augmentation block onto aportion of the first suture limb. The first suture limb and the firsttissue augmentation block are then disassociated from the firstthreader, and the first tissue augmentation block is advanced towardsthe first suture implant. A portion of the first suture limb is securedat a surgical site, and a location of the first tissue augmentationblock and/or the first suture limb is adjusted with respect to thetissue.

In some embodiments, the first suture can be coupled to the tissue byforming a medial row stitch with the first suture. Further, in someinstances the method can include coupling a second suture limb of thefirst suture to a second threader having a second tissue augmentationblock disposed thereon, the second suture limb being coupled to tissue,and applying a force to the second threader to move the second threaderwith respect to the second tissue augmentation block such that thesecond suture limb is passed into the second tissue augmentation blockto dispose the second tissue augmentation block onto a portion of thesecond limb. The second suture limb and the second tissue augmentationblock can be disassociated from the second threader. The second tissueaugmentation block can be advanced towards the first suture implant, anda portion of the second suture limb can be secured at the surgical site.In some embodiments in which the first suture includes both a firstsuture limb and second suture limb, the first and second suture limbscan be coupled together by way of a mattress stitch.

Various methods provided for can also include a second suture associatedwith a second suture implant. More specifically, a third suture limb ofa second suture can be coupled to a third threader having a third tissueaugmentation block disposed on it. The second suture can be attached toa second suture implant disposed in bone in a body, and the third suturelimb can be coupled to tissue. A force can be applied to the thirdthreader to move the threader with respect to the third tissueaugmentation block. As a result, the third suture limb can be passedinto the third tissue augmentation block to dispose the third tissueaugmentation block onto a portion of the third suture limb. The thirdsuture limb and the third tissue augmentation block can be disassociatedfrom the third threader, and a portion of the third suture limb can besecured at the surgical site. A portion of the first suture limb of thefirst suture can be secured at the surgical site by coupling the firstsuture limb to a first lateral anchor, a portion of the second suturelimb of the first suture can be secured at the surgical site by couplingthe second suture limb to a second lateral anchor, and a portion of thethird suture limb of the second suture can be secured at the surgicalsite by coupling the third suture limb to the second lateral anchor.Further, a portion of a fourth suture limb of the second suture can besecured at the surgical site by coupling the fourth suture limb to thefirst lateral anchor.

In some embodiments, the step of securing a portion of the first suturelimb at the surgical site can include coupling a second suture limb ofthe first suture with the first suture limb using a first knot. Further,the step of adjusting a location of at least one of the first tissueaugmentation block and first suture limb with respect to the tissue caninclude sliding the first tissue augmentation block over the first knot.In such embodiments, the method can also include coupling a third suturelimb and a fourth suture limb of a second suture that extend from thetissue with a second knot. Further, at least one of the third and fourthsuture limbs can extend above the first tissue augmentation block tohelp maintain a location of the first tissue augmentation block withrespect to the tissue.

In some other embodiments, the step of securing a portion of the firstsuture limb at the surgical site can include coupling a third suturelimb of a second suture that extends from the tissue with a first knotto form a mattress stitch. Further, the step of adjusting a location ofat least one of the first tissue augmentation block and first suturelimb with respect to the tissue can include sliding the first tissueaugmentation block over the first knot. In such embodiments, the methodcan also include coupling the second suture limb of the first suture anda fourth suture limb of the second suture with a second knot. Further,at least one of the second and fourth suture limbs can extend above thefirst tissue augmentation block to help maintain a location of the firsttissue augmentation block with respect to the tissue. Still further, alocation of the second suture can be laterally displaced with respect toa location of the first suture.

In still some other embodiments, the method can include coupling afourth suture limb of a second suture to a third threader having a thirdtissue augmentation block disposed on it. The fourth suture limb can becoupled to tissue. A force can be applied to the second threader to movethe second threader with respect to the second tissue augmentation blockso that the fourth suture limb is passed into the third tissueaugmentation block. As a result, the third tissue augmentation block isdisposed onto a portion of the fourth suture limb. The fourth suturelimb and the third tissue augmentation block can be disassociated fromthe third threader. A portion of a third suture limb, which is also fromthe second suture, can be secured within the body by coupling theportion to a first suture anchor that is disposed in bone. A portion ofthe fourth suture limb can also be secured within the body by couplingit to the first suture anchor. The second tissue augmentation block canbe disposed on the third suture limb, in addition to being disposed onthe second suture limb. Further, securing portions of the first andsecond suture limbs at the surgical site can include coupling a portionof the respective first and second suture limbs to a second sutureanchor disposed in bone.

The first tissue augmentation block, or any tissue augmentation blockfor that matter, can have a variety of configurations. For example, insome instances the first tissue augmentation block can have an openingextending through the block, and the opening can be configured to haveone of the suture limbs extending therethrough when the first tissueaugmentation block is disposed on the respective suture limb such thatthe first tissue augmentation block freely passes along a length of thesuture limb in an unrestricted manner. By way of further non-limitingexample, in some instances the first tissue augmentation block caninclude a tape having a substantially flat tissue-engaging surface witha width that is at least two times greater than a diameter of the suturelimb on which the block is disposed, and a length that is substantiallygreater than the width of the tape. The substantially flattissue-engaging surface can be configured to have the suture limb extendthrough it at a plurality of locations along the length of thesubstantially flat tissue-engaging surface when the tissue augmentationblock is disposed on the suture limb. Other configurations of tissueaugmentation blocks are also provided for, including but not limited tobars and washers. The washers can be sized such that a thickness of thewasher is substantially less than a length of a suture limb on which thewasher is to be disposed. Further, in some embodiments, the first tissueaugmentation block, or again any tissue augmentation block for thatmatter, can include at least one of: fabric, plastic, synthetic polymer,natural polymer, collagen, collagen scaffold, reconstituted collagen, abiological autograft, allograft, allogenic, xenogeneic, or xenograft,connective tissue including human dermal matrix, acellular porcinedermal matrix, acellular bovine dermal matrix, periosteal tissue,pericardial tissue, and/or fascia, and combinations thereof. In someembodiments, one or both of the first and second augmentation blocksincludes collagen. The blocks can be woven, non-woven, knitted, ormanufactured using a variety of techniques known to those skill in theart or otherwise provided for herein.

In one exemplary embodiment of a soft tissue repair system that includesa patch or scaffold, the system has a scaffold, a first threader, and asecond threader. Each of the first and second threaders include aproximal handle, a distal receiving end, and an intermediate portionextending between the proximal handle and the distal receiving end, andthe intermediate portion of each threader has the scaffold disposed onit. The first and second threaders are configured to dispose thescaffold onto sutures by associating respective sutures with therespective distal receiving ends and applying a force to the respectiveproximal handles to advance the respective distal receiving ends towardsthe scaffold.

The first and second threaders can be configured so that theirrespective distal receiving ends, and thus suture(s) associatedtherewith, pass through the scaffold in response to the application ofthe force to the proximal handles. In some embodiments, the intermediateportion of each of the first and second threaders can include a filamentportion, a fiber, a thread, a wire, a cord, and/or some other flexiblestructure. The proximal handles of the first and second suture threaderscan be disposed on a first side of the scaffold, the distal receivingends of the first and second threaders can be disposed on a second sideof the scaffold, and the intermediate portions of the first and secondthreaders can extend from the first side to the second side in apre-installation configuration.

In some embodiments, the intermediate portion of the first threader canbe disposed more proximate to a first side of the scaffold than asecond, opposite side of the scaffold, and the intermediate portion ofthe second threader can be disposed more proximate to the second,opposite side of the scaffold than the first side. Further, a thirdthreader and a fourth threader can also be provided, with each includinga proximal handle, a distal receiving end, and an intermediate portionextending between the proximal handle and the distal receiving end. Theintermediate portion of each of the third and fourth threaders can havethe scaffold disposed on it. Further, the third and fourth threaders canbe configured to dispose the scaffold onto sutures by associatingrespective sutures with the respective distal receiving ends andapplying a force to the respective proximal handles to advance therespective distal receiving ends towards the scaffold. In someembodiments, the intermediate portion of the third threader can bedisposed diagonally with respect to the scaffold such that the distalreceiving end of the third threader is proximate to the distal receivingend of the first threader and the proximal handle of the third threaderis proximate to the proximal handle of the second threader, and theintermediate portion of the fourth threader can be disposed diagonallywith respect to the scaffold such that the distal receiving end of thefourth threader is proximate to the distal receiving end of the secondthreader and the proximal handle of the fourth threader is proximate tothe proximal handle of the first threader.

The system can also include multiple sutures. For example, a firstsuture can be configured to be associated with the distal receiving endof the first threader and configured to have the scaffold disposed onit, and a second suture can similarly be configured to be associatedwith the distal receiving end of the second threader and configured tohave the scaffold disposed on it. In some embodiments, the suture(s) canbe coupled to the scaffold in a pre-installation configuration. By wayof example, a first suture can be coupled to the scaffold at a firstmedial location on the scaffold and a second suture can be coupled tothe scaffold at a second medial location on the scaffold. Each of thefirst and second sutures can include a hollow self-locking mechanism,and the intermediate portion of the first and second threaders can bedisposed in the hollow self-locking mechanisms of the first and secondsutures, respectively. Such a scaffold can include a flexible zone thatis located at the first and second medial locations, with the flexiblezone being configured to allow the scaffold to stretch.

In embodiments having the first and second sutures coupled to the firstand second medial locations as described, a leading tail can extend fromeach of the hollow self-locking mechanisms of the first and secondsutures, towards a first side of the scaffold. The leading tails can beconfigured to be coupled to the distal receiving ends of the first andsecond threaders disposed within the respective hollow self-lockingmechanisms of the first and second sutures. In some embodiments, atrailing tail can extend from each of the hollow self-locking mechanismsof the first and second sutures, towards a second, opposite side of thescaffold. Each of the trailing tails can be configured to be coupled toa suture anchor, whether the same anchor or different anchors. In someother embodiments, the system can include trailing tails that areseparate sutures than the first and second sutures. For example, a firsttrailing tail can be disposed more proximate to a second, opposite sideof the scaffold than the first side of the scaffold, and can also bedisposed more proximate to the hollow self-locking mechanism of thefirst suture than the hollow self-locking mechanism of the secondsuture. Similarly, a second trailing tail can be disposed more proximateto the second, opposite end of the scaffold than the first side of thescaffold, and can also be disposed more proximate to the hollowself-locking mechanism of the second suture than the hollow self-lockingmechanism of the first suture. Each of the trailing tails can beconfigured to be coupled to a suture anchor, whether the same anchor ordifferent anchors.

In some embodiments having the first and second sutures coupled to thefirst and second medial locations as described, third and fourththreaders and third and fourth sutures can also be provided. The thirdand fourth threaders can each include a proximal handle, a distalreceiving end, and an intermediate portion extending between theproximal handle and the distal receiving end. The intermediate portionof each of the third and fourth threaders can have the scaffold disposedon it, with the intermediate portion being associated with the third andfourth sutures. More specifically, the third and fourth sutures can becoupled to the scaffold proximate to the first and second mediallocations, respectively. Each of the third and fourth sutures caninclude a hollow self-locking mechanism, and the intermediate portionsof the third and fourth threaders can be disposed in the hollowself-locking mechanisms of the third and fourth sutures, respectively.Further, the third and fourth threaders can be configured to dispose thescaffold onto sutures by associating respective sutures with therespective distal receiving ends and applying a force to the respectiveproximal handles to advance the respective distal receiving ends towardsthe scaffold. In some embodiments, a leading tail can extend from eachof the hollow self-locking mechanisms of the first, second, third, andfourth sutures. The leading tails of the first and second sutures canextend towards a first side of the scaffold, and the leading tails ofthe third and fourth sutures can extend towards a second, opposite sideof the scaffold. The leading tails can be configured to be coupled tothe distal receiving ends of the first, second, third, and fourththreaders disposed within the respective hollow self-locking mechanismsof the first, second, third, and fourth sutures.

In some embodiments that include a scaffold and first and secondthreaders, one or more additional threaders can be provided. Forexample, a third threader and a fourth threader can be provided. Each ofthe third and fourth threaders can include a proximal handle, a distalreceiving end, and an intermediate portion extending between theproximal handle and the distal receiving end. The intermediate portionof each of the third and fourth threaders can have the scaffold disposedon it, with the third threader being configured to dispose the scaffoldonto the same suture as the first threader and the fourth threader beingconfigured to dispose the scaffold onto the same suture as the secondthreader. More particularly, the association of the third and fourththreaders with the same suture as the first and second threaders,respectively, can be configured to be achieved by associating therespective suture with the distal receiving end of the respective thirdand fourth threaders and applying a force to the proximal handle of therespective third and fourth threaders to advance the respective distalreceiving end towards the scaffold. The third and fourth threaders canbe disposed in the scaffold such that the distal receiving ends of thethird and fourth threaders are disposed on a tissue-engaging face of thescaffold and the proximal handles of the third and fourth threaders aredisposed on a face of the scaffold that is opposite of thetissue-engaging face.

A limb of the suture onto which the scaffold is disposed by the firstand third threaders can include a first loop that extends from thetissue-engaging face, around an edge of the scaffold to the face of thescaffold that is opposed to the tissue-engaging face, and into thescaffold at a first location on the scaffold, and a limb of the sutureonto which the scaffold is disposed by the second and fourth threaderscan include a second loop that extends from the tissue-engaging face,around the edge of the scaffold to the face of the scaffold that isopposed to the tissue-engaging face, and into the scaffold at a secondlocation on the scaffold in a post-installation configuration of thesystem. Alternatively, a limb of the suture onto which the scaffold isdisposed by the first and third threaders can include a first loop thatextends from the tissue-engaging face of the scaffold, to the face ofthe scaffold that is opposed to the tissue-engaging face, and into thescaffold at a first location on the scaffold that is offset from an edgeof the scaffold, and a limb of the suture onto which the scaffold isdisposed by the second and fourth threaders can include a second loopthat extends from the tissue-engaging face of the scaffold, to the faceof the scaffold that is opposed to the tissue-engaging face, and intothe scaffold at a second location that is offset from the edge of thescaffold in a post-installation configuration of the system.

The scaffold can have a variety of configurations, shapes, and sizes,and can be made of a variety of materials. In some embodiments, thescaffold can include at least one of: fabric, plastic, syntheticpolymer, natural polymer, collagen, collagen scaffold, reconstitutedcollagen, a biological autograft, allograft, allogenic, xenogeneic, orxenograft, connective tissue including human dermal matrix, acellularporcine dermal matrix, acellular bovine dermal matrix, periostealtissue, pericardial tissue, and/or fascia, and combinations thereof. Insome embodiments, the scaffold includes collagen. The scaffold can bewoven, non-woven, knitted, or manufactured using a variety of techniquesknown to those skill in the art or otherwise provided for herein. Stillfurther, in some embodiments a first layer of the scaffold can include abiodegradable polymer, and a second layer of the scaffold can include anextracellular matrix. A thickness of the first layer can be greater thana thickness of the second layer. Further, in some embodiments, thescaffold can include one or more adjustable suture loops disposed on anedge of the scaffold, the adjustable suture loop(s) being configured toprevent the scaffold from unintentionally sliding with respect to asuture limb passed through the respective adjustable suture loop(s).

In another exemplary embodiment of a soft tissue repair system, thesystem includes a scaffold and two sets of suture limbs. The scaffoldhas a first layer of material, and includes a tissue-facing surface anda second surface that is opposed to the tissue-facing surface, as wellas a medial edge and an opposed lateral edge. The first set of suturelimbs includes a first suture limb and a second suture limb that aredisposed through the scaffold between the tissue-facing surface and thesecond surface along a length of the scaffold that extends substantiallybetween the medial and opposed lateral edges. The second set of suturelimbs includes a third suture limb and a fourth suture limb that aredisposed above the tissue-facing surface of the scaffold. The system isconfigured such that a terminal lateral end of one of the first andsecond suture limbs and a terminal lateral end of one or the third andfourth suture limbs are disposed proximate to each other on a first sideof the scaffold, and a terminal lateral end of the other of the firstand second suture limbs and a terminal lateral end of the other of thethird and fourth suture limbs are disposed proximate to each other on asecond side of the scaffold. The first and second sides of the scaffoldare distinguished by being on opposite sides of a central longitudinalaxis of the scaffold that extends between the medial and lateral edges.Further, at least one of the first and second suture limbs extendsthrough the scaffold from the tissue-facing surface to the secondsurface and then, for that suture limb, forms at least one stitch thatpasses a terminal lateral end of the suture limb through the scaffold toand through the lateral edge. Optionally, a stitch of that nature, orsimilar to that nature, can also be formed with at least one of thethird and fourth suture limbs.

The scaffold can include a second layer of material disposed above thefirst layer of material such that the second layer of material isdisposed above the tissue-facing surface of the scaffold and the secondlayer of material includes the second surface of the scaffold. In suchembodiments, the first suture limb and the second suture limb can bedisposed between a top-most surface of the first layer of material thatis opposed to the tissue-facing surface of the scaffold and atissue-facing surface of the second layer of material that is opposed tothe second surface of the scaffold.

In some embodiments, the first and second suture limbs can be disposedon opposite sides of the central longitudinal axis of the scaffold suchthat the first and second suture limbs do not intersect at locations atwhich the first and second suture limbs are disposed through thescaffold between the tissue-facing surface and the second surface. Insome such embodiments, the third and fourth suture limbs can be disposedwith respect to the central longitudinal axis of the scaffold such thatthe third and fourth suture limbs cross over the central longitudinalaxis at least once and intersect each other at least once at a locationat which the third and fourth suture limbs are disposed above each ofthe tissue-facing surface and the second surface. In some other suchembodiments, the third and fourth suture limbs can be disposed onopposite sides of the central longitudinal axis of the scaffold suchthat the first and fourth suture limbs do not intersect at location atwhich the third and fourth suture limbs are disposed above each of thetissue-facing surface and the second surface and are in contact with thesecond surface. The first set of the suture limbs can be disposedfurther from the central longitudinal axis than the second set of thesuture limbs for portions of the limbs that extend between the medialand lateral edges. Alternatively, the second set of the suture limbs canbe disposed further from the central longitudinal axis than the firstset of the suture limbs for portions of the limbs that extend betweenthe medial and lateral edges.

In some other embodiments, the first and second suture limbs can bedisposed with respect to the central longitudinal axis of the scaffoldsuch that the first and second suture limbs cross over the centrallongitudinal axis at least once and intersect each other at least onceat a location at which the first and second suture limbs are disposedthrough the scaffold between the tissue-facing surface and the secondsurface. In some such embodiments, the third and fourth suture limbs canbe disposed with respect to the central longitudinal axis of thescaffold such that the third and fourth suture limbs also cross over thecentral longitudinal axis at least once and intersect each other atleast once at a location at which the third and fourth suture limbs aredisposed above each of the tissue-facing surface and the second surface.In some other such embodiments, the third and fourth suture limbs can bedisposed on opposite sides of the central longitudinal axis of thescaffold such that the first and fourth suture limbs do not intersect atlocation at which the third and fourth suture limbs are disposed aboveeach of the tissue-facing surface and the second surface and are incontact with the second surface.

The third and fourth suture limbs can be disposed above the secondsurface of the scaffold. Further, in some embodiments, the third andfourth suture limbs can be in contact with the second surface of thescaffold. Alternatively, the third and fourth suture limbs can bedisposed through the scaffold between the tissue-facing surface and thesecond surface along a portion of a length of the scaffold that extendsbetween the medial and opposed lateral edges. Further alternatively, thethird and fourth suture limbs can partially extend above the secondsurface of the scaffold and partially through the scaffold. Forinstance, a portion of the third and fourth suture limbs extendingbetween the medial and opposed lateral edges can be disposed above thesecond surface of the scaffold and another portion of the third andfourth suture limbs can be disposed through the scaffold between thetissue-facing surface and the second surface along the portion of thelength of the scaffold that extends between the medial and opposedlateral edges.

The at least one stitch can include a loop in which the suture limbforming the loop passes around the medial edge and into the scaffoldsuch that the terminal lateral end of the suture limb passes through thescaffold from the medial edge to and through the lateral edge.Alternatively, the at least one stitch can include a jog in which thesuture limb forming the jog passes into the scaffold at an entrylocation on the second surface that is more proximate to the medial edgethan the lateral edge along a longitudinal axis extending substantiallyparallel to the central longitudinal axis of the scaffold such that theterminal end of the suture limb passes through the scaffoldapproximately from the entry location to and through the lateral edge.At least one of the third and fourth suture limbs can also extendthrough the scaffold from the tissue-facing surface to the secondsurface and then, for that suture limb, form at least one stitch thatpasses a terminal lateral end of the suture limb through the scaffold toand through the lateral edge. The stitch can likewise be a loop or jog.

The first set of suture limbs can extend from a first mattress stitchand a second set of suture limbs can extend from a second mattressstitch. The system can further include at least one additional suturehaving a fifth suture limb and a sixth suture limb. In some embodiments,the fifth and sixth suture limbs can extend from a central medialmattress stitch, while in some other embodiments the fifth and sixthsuture limbs can extend from a central lateral mattress stitch. In stillfurther embodiments, suture limbs can extend from each of a centralmedial mattress stitch and a central lateral mattress stitch. Whether acentral medial or lateral mattress stitch, the system can be configuredsuch that a terminal lateral end of one of the fifth and sixth suturelimbs can be disposed proximate to the terminal lateral ends of therespective first, second, third, and fourth suture limbs that aredisposed on the first side of the scaffold, and a terminal lateral endof the other of the fifth and sixth suture limbs can be disposedproximate to the terminal lateral ends of the respective first, second,third, and fourth suture limbs that are disposed on the second side ofthe scaffold.

Exemplary methods of soft tissue repair that include using a patch orscaffold are also disclosed. One exemplary method includes passing eachof a first suture limb and a second suture limb through soft tissue andattaching a scaffold to each of the first and second suture limbs. Thisresults in a surface area for engaging tissue associated with each ofthe first and second suture limbs being increased. A first end of thescaffold is advanced to a location that is proximate to locationsthrough which the first and second suture limbs pass through the softtissue, and one or more suture tails are coupled to at least one sutureanchor that is disposed in the bone to which the soft tissue is beingattached. In some embodiments, the one or more suture tails are part ofsuture from which the first and second limbs are formed, while in otherembodiments the one or more suture tails are separate sutures fromsutures that form the first and second suture limbs.

The step of advancing a first end of the scaffold to a location that isproximate to locations through which the first and second suture passesthrough the soft tissue can included disposing a second, opposite end ofthe scaffold beyond the soft tissue such that it extends over bone towhich the soft tissue is being attached. In some embodiments, the stepof attaching a scaffold to each of the first and second suture limbs caninclude threading each of the first and second suture limbs from thefirst end of the scaffold to the second, opposite end of the scaffold,with the first suture limb being thread at a location that is moreproximate to a first side of the scaffold than a second, opposite sideof the scaffold and the second suture limb being thread at a locationthat is more proximate to the second, opposite side of the scaffold thanthe first side of the scaffold. In such embodiments, the step ofcoupling one or more suture tails with at least one suture anchordisposed in the bone to which the soft tissue is being attached caninclude coupling a first tail of the one or more suture tails with afirst suture anchor disposed in the bone to which the soft tissue isbeing attached and coupling a second tail of the one or more suturetails with a second suture anchor disposed in the bone to which the softtissue is being attached. The first suture limb can be of a first sutureand the second suture limb can be of a second suture. In someembodiments, the step of attaching a scaffold to each of the first andsecond suture limbs can include disposing at least one of the first andsecond suture limbs through an opening of a loop disposed on an edge ofthe scaffold and collapsing the opening of the loop through which thefirst and/or second suture limbs are disposed around the respectivelimb(s) to prevent the scaffold from unintentionally sliding withrespect to the limb(s) disposed through the opening.

In embodiments having the first suture and the second suture, threadingthe first suture limb from the first end of the scaffold to the second,opposite end of the scaffold can include coupling the first suture limbto a threader disposed in the scaffold and applying a force to thethreader to dispose the scaffold onto the first suture limb. Similarly,threading the second suture limb from the first end of the scaffold tothe second, opposite end of the scaffold can include coupling the secondsuture limb to a threader disposed in the scaffold and applying a forceto the threader to dispose the scaffold onto the second suture limb.

In embodiments having the first suture and the second suture, the methodcan include installing a first medial row stitch using the first suture,and installing a second medial row stitch using the second suture.Further, the step of coupling one or more suture tails with at least onesuture anchor disposed in the bone to which the soft tissue is beingattached can include installing a lateral row fixation.

The step of attaching a scaffold to each of the first and second suturelimbs can include disposing the first suture limb through the scaffoldfrom a tissue-engaging face of the scaffold to a face of the scaffoldthat is opposed to the tissue-engaging face, with the disposing of thefirst suture limb occurring at a first location on the scaffold that isproximate to a proximal edge of the scaffold. The attachment step canfurther include passing the first suture limb around the proximal edgeof the scaffold and into the scaffold through the proximal edge to forma first loop, and passing the first suture limb through the scaffoldfrom the proximal edge to a distal edge of the scaffold. The step canalso include disposing the second suture limb through the scaffold fromthe tissue-engaging face of the scaffold to the face of the scaffoldthat is opposed to the tissue-engaging face, with the disposing of thesecond suture limb occurring at a second location on the scaffold thatis proximate to the proximal edge of the scaffold. The attachment stepcan still further include passing the second suture limb around theproximal edge of the scaffold and into the scaffold through the proximaledge to form a second loop, and passing the second suture limb throughthe scaffold from the proximal edge to the distal edge of the scaffold.

Alternatively, the step of attaching a scaffold to each of the first andsecond suture limbs can include disposing the first suture limb throughthe scaffold from a tissue-engaging face of the scaffold to a face ofthe scaffold that is opposed to the tissue-engaging face, with thedisposing of the first suture limb occurring at a first location on thescaffold that is proximate to a proximal edge of the scaffold. Theattachment step can further include passing the first suture limb backinto the scaffold through the face of the scaffold that is opposed tothe tissue-engaging face, with the passing of the first suture limb backinto the scaffold occurring at a second location on the scaffold that isoffset from the first location to form a first stitch. The attachmentstep can also include passing the first suture limb through the scaffoldfrom the second location to a distal edge of the scaffold. Theattachment step can still further include disposing the second suturelimb through the scaffold from the tissue-engaging surface of thescaffold to the face of the scaffold that is opposed to thetissue-engaging face, with the disposing of the second suture limboccurring at a third location on the scaffold that is proximate to theproximal edge of the scaffold. The attachment step can also includepassing the second suture limb back into the scaffold through the faceof the scaffold that is opposed to the tissue-engaging face, with thepassing of the second suture limb back into the scaffold occurring at afourth location on the scaffold that is offset from the third locationto form a second stitch. Still further, the attachment step can includepassing the second suture limb through the scaffold from the fourthlocation to the distal edge of the scaffold.

The first suture can include a third suture limb and the second suturecan include a fourth suture limb. In such embodiments, which alsoinclude the first and second suture anchors, the method can furtherinclude passing the third suture limb over the scaffold and coupling itto the second suture anchor, and passing the fourth suture limb over thescaffold and coupling it to the first suture anchor. Further, a firstmedial anchor to which the first suture is coupled and a second medialanchor to which the second suture is coupled can be installed such thatthe first and third suture limbs extend from the first medial anchor andthe second and fourth suture limbs extend from the second medial anchor.

In other embodiments that include the third and fourth suture limbs, themethod can include threading the third suture limb from the first end ofthe scaffold to the second, opposite end of the scaffold and couplingthe third suture limb to the second suture anchor. Similarly, the fourthsuture limb can be threaded from the first end of the scaffold to thesecond, opposite end of the scaffold and coupled to the first sutureanchor. The resulting configuration can be a crossed configurationbetween the third and fourth suture limbs. Further, a first medialanchor to which the first suture is coupled and a second medial anchorto which the second suture is coupled can be installed such that thefirst and third suture limbs extend from the first medial anchor and thesecond and fourth suture limbs extend from the second medial anchor.

Carrying forward with some embodiments having four suture limbs,threading the first suture limb from the first end of the scaffold tothe second, opposite end of the scaffold can include coupling the firstsuture limb to a threader disposed in the scaffold and applying a forceto the threader to dispose the scaffold onto the first suture limb.Similarly, threading each of the second, third, and fourth suture limbsfrom the first end of the scaffold to the second, opposite end of thescaffold can include coupling the second, third, and fourth suture limbsto respective threaders disposed in the scaffold and applying a force toeach of the threader to dispose the scaffold onto each of the second,third, and fourth suture limbs.

In some embodiments, the first suture limb can be coupled to a firstmedial location on the scaffold and can include a hollow self-lockingmechanism with a first threader disposed in that hollow self-lockingmechanism, and the second suture limb can be coupled to a second mediallocation on the scaffold and can include a hollow self-locking mechanismwith a second threader disposed in that hollow self-locking mechanism.In such embodiments the method can include coupling a leading tail ofthe first suture limb to the soft tissue and subsequently to the firstthreader, and coupling a leading tail of the second suture limb to thesoft tissue and subsequently to the second threader. The first andsecond threaders can be moved with respect to the hollow self-lockingmechanisms of the respective first and second suture limbs to pass theleading tail of the first and second suture limbs through the hollowself-locking mechanisms of that same limb. The step of advancing a firstend of the scaffold to a location that is proximate to locations throughwhich the first and second limbs pass through the tissue can includeapplying a force to the leading tails for the first and second suturelimbs after they have passed through the respective hollow self-lockingmechanism to advance the first end of the scaffold. Further, the step ofcoupling the one or more suture tails with at least one suture anchordisposed in the bone to which the soft tissue is being attached caninclude coupling a first trailing tail of the one or more suture tailsto one of a first and second suture anchor of the at least one sutureanchor disposed in the bone to which the soft tissue is being attached,and coupling a second trailing tail of the one or more suture tails tothe other of the first and second suture anchors of the at least onesuture anchor disposed in the bone to which the soft tissue is beingattached. In some embodiments, the first trailing tail is part of thefirst suture and the second trailing tail is part of the second suture.In some other embodiments, the first trailing tail and the secondtrailing tail are separate sutures than the first and second sutures.

In some other embodiments having four suture limbs, the first suturelimb can be coupled to the scaffold at a first medial location on thescaffold and can include a hollow self-locking mechanism with a firstthreader disposed in that hollow self-locking mechanism, and the secondsuture limb can be coupled to the scaffold at a second medial locationon the scaffold and can include a hollow self-locking mechanism with asecond threader disposed in that hollow self-locking mechanism. Further,a third suture limb of a third suture can be coupled to the scaffoldproximate to the first medial location on the scaffold and a fourthsuture limb of a fourth suture can be coupled to the scaffold proximateto the second medial location on the scaffold. The third and fourthsuture limbs can each include a hollow self-locking mechanism havingthird and fourth threaders disposed in the hollow self-lockingmechanisms of the respective third and fourth limbs. In such embodimentsthe method can include coupling a leading tail of the first suture limbto the soft tissue and subsequently to the first threader, and couplinga leading tail of the second suture limb to the soft tissue andsubsequently to the second threader. The first and second threaders canbe moved with respect to the hollow self-locking mechanisms of therespective first and second suture limbs to pass the leading tail of thefirst and second suture limbs through the hollow self-locking mechanismsof that same limb. The step of advancing a first end of the scaffold toa location that is proximate to locations through which the first andsecond limbs pass through soft tissue can include applying a force tothe leading tails for the first and second suture limbs after they havepassed through the respective hollow self-locking mechanism to advancethe first end of the scaffold. Further, the step of coupling the one ormore suture tails with at least one suture anchor disposed in the boneto which the soft tissue is being attached can include coupling theleading tail of the third suture limb to a collapsible loop coupled to afirst suture anchor of the at least one suture anchor disposed in thebone to which the soft tissue is being attached and subsequently to thethird threader, and coupling the leading tail of the fourth suture limbto a collapsible loop coupled to a second suture anchor of the at leastone suture anchor disposed in the bone to which the soft tissue is beingattached and subsequently to the fourth threader. The third and fourththreaders can be moved with respect to the hollow self-lockingmechanisms of the respective third and fourth suture limbs to pass theleading tail of the third and fourth suture limbs through the hollowself-locking mechanisms of that same limb. A force can be applied to theleading tails of the third and fourth suture limbs after they havepassed through the respective hollow self-locking mechanism to advancethe second, opposite end of the scaffold towards the bone to which thesoft tissue is being attached.

In some embodiments, the scaffold can include at least one of: fabric,plastic, synthetic polymer, natural polymer, collagen, collagenscaffold, reconstituted collagen, a biological autograft, allograft,allogenic, xenogeneic, or xenograft, connective tissue including humandermal matrix, acellular porcine dermal matrix, acellular bovine dermalmatrix, periosteal tissue, pericardial tissue, and/or fascia, andcombinations thereof. In some embodiments, the scaffold includescollagen. The scaffold can be woven, non-woven, knitted, or manufacturedusing a variety of techniques known to those skill in the art orotherwise provided for herein.

Unless otherwise specified, the steps of the methods provided for in thepresent disclosure can be performed in any order.

BRIEF DESCRIPTION OF DRAWINGS

FIG. 1A is a top view of one exemplary embodiment of a tissueaugmentation construct;

FIG. 1B is a side view of the tissue augmentation construct of FIG. 1A;

FIG. 2A is a perspective side view of another exemplary embodiment of atissue augmentation construct;

FIG. 2B is a side view of the tissue augmentation construct of FIG. 2Ahaving a threader disposed therein;

FIG. 2C is a perspective view of the tissue augmentation construct ofFIG. 2B;

FIG. 2D is a front view of the tissue augmentation construct of FIG. 2A;

FIG. 2E is a perspective view of yet another exemplary embodiment of atissue augmentation construct;

FIG. 2F is a perspective view of still another exemplary embodiment of atissue augmentation construct;

FIG. 2G is a side view of another exemplary embodiment of a tissueaugmentation construct;

FIG. 2H is a side view of still another exemplary embodiment of a tissueaugmentation construct;

FIG. 2I is a side view of yet another exemplary embodiment of a tissueaugmentation construct;

FIG. 3 is a side view of one exemplary tissue augmentation constructinstallation tool, the tool having a tissue augmentation similar to thetissue augmentation construct of FIG. 2A associated therewith;

FIG. 4 is a perspective view of another exemplary embodiment of a tissueaugmentation construct;

FIG. 5 is a perspective view of still another exemplary embodiment of atissue augmentation construct;

FIGS. 6A-6C are schematic sequential views of one exemplary embodimentfor installing tissue augmentation constructs in a double row fixation;

FIGS. 7A-7D are schematic sequential views of another exemplaryembodiment for installing tissue augmentation constructs in a double rowfixation;

FIG. 8A is a schematic view of still another exemplary embodiment forinstalling tissue augmentation constructs in a double row fixation;

FIG. 8B is a schematic view of another exemplary embodiment forinstalling tissue augmentation constructs in a double row fixation;

FIG. 9 is a schematic view of yet another exemplary embodiment forinstalling tissue augmentation constructs in a double row fixation;

FIGS. 10A-10E are schematic sequential views of one exemplary embodimentfor installing the tissue augmentation construct of FIG. 2G in a doublerow fixation;

FIGS. 11A-11C are schematic sequential views of one exemplary embodimentfor installing tissue augmentation constructs in a single row fixation;

FIG. 11D is a schematic view of another exemplary embodiment forinstalling tissue augmentation constructs in a single row fixation;

FIG. 11E is a schematic view of still another exemplary embodiment forinstalling tissue augmentation constructs in a single row fixation;

FIG. 11F is a schematic view of another exemplary embodiment forinstalling tissue augmentation constructs in a single row fixation;

FIG. 12 is a schematic view of yet another exemplary embodiment forinstalling tissue augmentation constructs in a single row fixation;

FIG. 13 is a schematic view of another exemplary embodiment forinstalling tissue augmentation constructs in a single row fixation;

FIG. 14 is a schematic view of still another exemplary embodiment forinstalling tissue augmentation constructs in a single row fixation;

FIG. 15 is a schematic view of another exemplary embodiment forinstalling tissue augmentation constructs in a single row fixation;

FIGS. 16A-16C are schematic views of yet another exemplary embodimentfor installing tissue augmentation constructs in a single row fixation;

FIGS. 17A-17D are schematic sequential views of one exemplary embodimentfor repairing soft tissue;

FIGS. 18A-18C are schematic sequential views of another exemplaryembodiment for repairing soft tissue;

FIG. 19 is a schematic view of still another exemplary embodiment forrepairing soft tissue;

FIGS. 20A-20C are schematic sequential views of another exemplaryembodiment for repairing soft tissue;

FIGS. 20D-20F are schematic sequential views of yet another exemplaryembodiment for repairing soft tissue;

FIG. 21A is a schematic view of an exemplary embodiment of a tissueaugmentation construct;

FIGS. 21B-21F are schematic sequential views of one exemplary embodimentfor installing the tissue augmentation construct of FIG. 21A;

FIG. 21G is a schematic view of another exemplary embodiment forinstalling the tissue augmentation constructs of FIG. 21A;

FIG. 21H is a schematic view of an alternative exemplary embodiment ofthe tissue augmentation construct of FIG. 21A;

FIG. 21I is a schematic view of another alternative exemplary embodimentof the tissue augmentation construct of FIG. 21A;

FIGS. 22A-22C are schematic sequential views of one exemplary embodimentfor manufacturing the tissue augmentation construct of FIG. 2A;

FIG. 23A is a front view of a plurality of tissue augmentationconstructs during an exemplary embodiment for manufacturing tissueaugmentation constructs;

FIG. 23B is a top view of the plurality of tissue augmentationconstructs of FIG. 23A;

FIG. 23C is a front view of one tissue augmentation construct of theplurality of tissue augmentation constructs of FIG. 23A;

FIG. 24A is a front view of a plurality of tissue augmentationconstructs during another exemplary embodiment for manufacturing tissueaugmentation constructs;

FIG. 24B is a top view of the plurality of tissue augmentationconstructs of FIG. 23A;

FIG. 24C is a front view of one tissue augmentation construct of theplurality of tissue augmentation constructs of FIG. 23A;

FIG. 25 is a side view of one exemplary embodiment of a distal end of atool for manufacturing the tissue augmentation construct of FIG. 2A;

FIGS. 26A-26C are schematic sequential views of another exemplaryembodiment for manufacturing a tissue augmentation construct;

FIG. 26D is a side view of one tissue augmentation construct that canresult from the manufacturing process illustrated in FIGS. 26A-26C;

FIG. 26E is a side view of an alternative tissue augmentation constructthat can result from the manufacturing process illustrated in FIGS.26A-26C;

FIG. 26F is a top view of the tissue augmentation construct of FIG. 26E;

FIGS. 26G-26I are schematic sequential views of yet another exemplaryembodiment for manufacturing a tissue augmentation construct;

FIG. 27A is a schematic side view of one exemplary embodiment of atunneling station for use in manufacturing a tissue augmentationconstruct;

FIGS. 27B and 27C are side schematic views of a support of the tunnelingstation of FIG. 27A;

FIGS. 27D-27I are various exemplary embodiments of distal ends of lumenformation tools that can be used in conjunction with the tunnelingstation of FIG. 27A;

FIGS. 27J-27L are schematic sequential views of one exemplary embodimentfor manufacturing a tissue augmentation construct using the tunnelingstation of FIG. 27A;

FIG. 27M is a schematic side view of another exemplary embodiment of atunneling station for use in manufacturing a tissue augmentationconstruct;

FIG. 28 is a side view of one exemplary embodiment of a tissueaugmentation construct;

FIG. 29A is a perspective view of another exemplary embodiment of atissue augmentation construct;

FIG. 29B is a perspective view of the tissue augmentation construct ofFIG. 29A installed at a surgical site;

FIG. 30A is a side view of another exemplary embodiment of a tissueaugmentation construct;

FIG. 30B is a top view of the tissue augmentation construct of FIG. 30A;

FIGS. 30C-30E are schematic sequential views of an exemplary embodimentfor manufacturing the tissue augmentation construct of FIG. 30A;

FIG. 30F is a schematic view of one exemplary embodiment for installingthe tissue augmentation construct of FIG. 30A;

FIGS. 30G-301 are schematic sequential views of one exemplary embodimentfor installing a tissue augmentation construct similar to that of FIG.30A;

FIG. 30J is a perspective view of still another exemplary embodiment ofa tissue augmentation construct, the tissue augmentation constructhaving collapsible loops disposed thereon;

FIG. 30K is a perspective view of the tissue augmentation construct ofFIG. 30J having suture limbs passed through the collapsible loops;

FIG. 30L is a schematic view of one exemplary embodiment for installingthe tissue augmentation construct of FIG. 30J;

FIG. 31A-31C are schematic sequential views of a further exemplaryembodiment for manufacturing a tissue augmentation construct;

FIG. 32A is a top view of still another exemplary embodiment of a tissueaugmentation construct;

FIGS. 32B-32E are schematic sequential views of one exemplary embodimentfor installing the tissue augmentation construct of FIG. 32A;

FIGS. 32F-32H are schematic sequential views of one exemplary embodimentfor installing a tissue augmentation construct similar to that of FIG.32A;

FIGS. 32I-32J are schematic sequential views of one exemplary embodimentfor manufacturing the tissue augmentation construct of FIG. 32A;

FIGS. 33A-33E are schematic top views of various exemplary embodimentsof tissue augmentation constructs and suture configurations;

FIG. 34A is a top view of another exemplary embodiment of a tissueaugmentation construct;

FIG. 34B is a side view of the tissue augmentation construct of FIG.34A;

FIGS. 34C-34J are schematic sequential views of one exemplary embodimentfor installing the tissue augmentation construct of FIG. 34A;

FIG. 34K is a schematic view of another exemplary embodiment forinstalling the tissue augmentation construct of FIG. 34A;

FIG. 35A is a top view of still another exemplary embodiment of a tissueaugmentation construct;

FIG. 35B is a side view of the tissue augmentation construct of FIG.35A;

FIGS. 35C and 35D are schematic sequential views of one exemplaryembodiment for installing the tissue augmentation construct of FIG. 35A;

FIG. 36A is a top view of another exemplary embodiment of a tissueaugmentation construct;

FIG. 36B is a side view of the tissue augmentation construct of FIG.36A;

FIGS. 36C-36I are schematic sequential views of one exemplary embodimentfor installing the tissue augmentation construct of FIG. 36A;

FIGS. 37A-37E are schematic sequential views of one exemplary embodimentfor installing a tissue augmentation construct;

FIG. 38A is a top view of one exemplary embodiment of a tissueaugmentation construct management device;

FIG. 38B is a bottom view of the tissue augmentation constructmanagement device of FIG. 38A;

FIG. 38C is a schematic side view of a release mechanism of the tissueaugmentation construct management device of FIG. 38A;

FIG. 38D is a schematic side view of an alternative exemplary releasemechanism that can be used in conjunction with a tissue augmentationconstruct management device like the device of FIG. 38A;

FIG. 38E is a top view of another exemplary embodiment of a tissueaugmentation construct management device;

FIG. 38F is a perspective exploded view of the tissue augmentationconstruct management device of FIG. 38E;

FIG. 38G is a top view of a threader of the tissue augmentationconstruct management device of FIG. 38A;

FIG. 38H is a rear perspective view of the threader of FIG. 38G;

FIGS. 39A-39F are schematic sequential views illustrating a method forusing still another exemplary embodiment of a tissue augmentationconstruct management device;

FIG. 40 is a perspective view of another exemplary embodiment of atissue augmentation construct management device;

FIG. 41A is a perspective view of another exemplary embodiment of atissue augmentation construct;

FIGS. 41B-41D are various exemplary embodiments of distal ends ofdelivery tools that can be used with the tissue augmentation constructof FIG. 41A;

FIG. 41E is a perspective view of the delivery tool of FIG. 41B beingused to deliver the tissue augmentation construct of FIG. 41A;

FIG. 42A is a side cross sectional view of yet another exemplaryembodiment of a delivery tool for delivering a tissue augmentationconstruct;

FIGS. 42B and 42C are schematic sequential views of the delivery tool ofFIG. 42A being used to deliver a tissue augmentation construct; and

FIG. 43 is a schematic view of one exemplary embodiment of a sutureleader.

DETAILED DESCRIPTION

Certain exemplary embodiments will now be described to provide anoverall understanding of the principles of the structure, function,manufacture, and use of the devices and methods disclosed herein. One ormore examples of these embodiments are illustrated in the accompanyingdrawings. Those skilled in the art will understand that the devices andmethods specifically described herein and illustrated in theaccompanying drawings are non-limiting exemplary embodiments and thatthe scope of the present disclosure is defined solely by the claims. Thefeatures illustrated or described in connection with one exemplaryembodiment may be combined with the features of other embodiments. Suchmodifications and variations are intended to be included within thescope of the present disclosure. Further, in the present disclosure,like-numbered components of the embodiments generally have similarfeatures. Additionally, to the extent that linear or circular dimensionsare used in the description of the disclosed systems, devices, andmethods, such dimensions are not intended to limit the types of shapesthat can be used in conjunction with such systems, devices, and methods.A person skilled in the art will recognize that an equivalent to suchlinear and circular dimensions can easily be determined for anygeometric shape. Sizes and shapes of the systems and devices, and thecomponents thereof, can depend at least on the anatomy of the subject inwhich the systems and devices will be used, the size and shape ofcomponents with which the systems and devices will be used, and themethods and procedures in which the systems and devices will be used.

The figures provided herein are not necessarily to scale. Still further,to the extent arrows are used to describe a direction of movement, thesearrows are illustrative and in no way limit the direction the respectivecomponent can or should be moved. A person skilled in the art willrecognize other ways and directions for creating the desired result inview of the present disclosure. Additionally, a number of terms may beused throughout the disclosure interchangeably but will be understood bya person skilled in the art. By way of non-limiting example, the termssuture, filament, and flexible members may be used interchangeably, andincludes other similarly purposed materials, such as suture tape.Further, to the extent the term “block” is used to describe some of theconstructs and matrices provided for herein, the constructs and matricesare not limited to a square or a rectangle, or any shape having flatsurfaces for that matter. Still further, to the extent the term “thread”is used to describe associating one component with another, the term isnot limited to mean actually passing filament through another material.It can also include passing it through an opening (e.g., an openingformed in a body, as described below at least with respect to sometissue augmentation blocks), and thus can more generally meanassociating one component with another.

Systems, devices, and methods for soft tissue repair are generallyprovided, with such systems or devices including but not being limitedto: one or more surgical repair filaments and/or flexible members; oneor more tissue augmentation constructs or matrices, which includestrips, tubes, bars, tacks, washers, and/or patches, each of which isdescribed in greater detail below; and one or more suture implants orsimilarly configured or purposed devices. The terms “tissue augmentationconstruct” and “tissue augmentation matrix” may also be interchangeablyused with the terms “suture augmentation construct” and “sutureaugmentation matrix,” as well as more generally with the terms“augmentation construct” and “augmentation matrix,” and the terms“construct” and “matrix.” As described herein, the term “construct”refers to any implant associated with suture limbs to expand thefootprint of the limb, the term “block” refers to a subset of constructsthat includes strips or tapes, tubes, bars, washers, and othercannulated bodies, and the terms “tack” or “button,” and “patches” or“scaffold” are described in greater detail below (as are the termsstrips, tapes, tubes, bars, and washers, among others). Surgical repairfilaments or flexible members can come in a variety of configurationsincluding in typical suture configurations and tape forms, and can beused in connection with a variety of types of suture implants, e.g.,filament anchors, suture anchors, or bone anchors, including hard andsoft anchors, to attach or reattach soft tissue to bone. The repairfilaments can pass through soft tissue so that the soft tissue can bepositioned in a desired location. The repair filaments are secured toanchors which, in turn, are fixed in bone. The tissue augmentationconstruct(s) can be associated with the surgical repair filaments toincrease coverage and bulk to compromised or degenerate soft tissue, toincrease a surface area along which compression between the suturerepair filament and tissue being repaired is applied, and to helppromote tissue growth and repair. While each of the repair filament,tissue augmentation construct, and suture implant is described as beingpart of the systems or devices, any one component can be provided forseparately for use with the other components or other implants anddevices used in surgical procedures.

While many different repair procedures can be enhanced by the presentdisclosures, in some exemplary embodiments the soft tissue repairdevices and systems provided for herein can be used for rotator cufffixation procedures. In rotator cuff fixation procedures a surgeon canreattach the rotator cuff to the bone by first threading a suturethrough the soft tissue such that two suture limbs extend from thetissue. The surgeon can thread each of the suture limbs throughrespective tissue augmentation constructs, and subsequently fix thesuture limbs to one or more bone anchors proximate to the tissue. Thetissue augmentation constructs increase the surface area, or footprint,of the system that contacts the soft tissue. This enlarged footprint maydisperse any loading forces on the soft tissue, and, as a result, thetensioned suture may be less likely to abrade or otherwise damage thesoft tissue, for instance by “cheese wiring.” Moreover, the tissueaugmentation constructs can be easily and quickly threaded onto orotherwise associated with suture limbs during the procedure, whichcontrasts from existing systems that involved complicated,time-intensive approaches for associating xenograft or allograftformations with suture limbs. The resulting procedures thus allow forthe tissue augmentation constructs to be added onto suture limbs in anon-demand fashion. Still further, the tissue augmentation constructs canbe made from biocompatible materials (e.g., collagen), among other typesof materials, such that during healing new bands of tissue growth canoccur, further increasing the efficacy of the rotator cuff fixationprocedure. In other non-limiting exemplary embodiments disclosed herein,the soft tissue repair devices and systems can be used in other softtissue repair procedures for example, repair of torn anterior cruciateligament (ACL), instability or glenoid procedures, meniscal repair,superior capsule reconstruction, and hip capsular closure, among others.Various methods of manufacturing the tissue augmentation constructs, aswell as using installation tools and/or threaders to associate tissueaugmentation constructs with operative sutures are also described.

Tissue Augmentation Constructs—Tissue Augmentation Blocks Having a Stripor Tape Configuration

One exemplary embodiment of a tissue augmentation construct, as shown atissue augmentation block 10, is provided for in FIGS. 1A and 1B. In oneexemplary embodiment, the tissue augmentation block 10 is a strip ortape configured to be threaded onto or otherwise associated with asuture limb 12 a. More particularly, the tissue augmentation strip ortape 10 can have a substantially rectangular shape with a width W,length L, and thickness T, and includes a substantially flat,tissue-engaging surface 10 a and/or 10 b. As shown, the tape 10 islonger than it is wide and wider than it is thick. Typically the lengthL is substantially greater than the width W and the width W issubstantially greater than the thickness T. Further, the width W can begreater than a diameter of a filament or suture with which the tissueaugmentation tape 10 is associated, e.g., the suture limb 12 a, therebyincreasing the surface area of compression of the system or device usedin the surgical repair.

A person skilled in the art will recognize that the dimensions of thelength L, width W, and thickness T of the tissue augmentation strip 10can depend on a variety of factors, including but not limited to thesize of the filament with which it is to be associated, the anatomy ofthe patient, and the type of procedure being performed. In someembodiments a ratio of the width W of the strip 10 to a diameter of thesuture limb 12 a can be approximately in the range of about 2:1 to about20:1, and more particularly the width W can be at least three timesgreater than the diameter of the filament or suture with which thetissue augmentation strip 10 is associated in some instances. Inembodiments in which the suture limb 12 a is a suture tape, the width Wof the tissue augmentation strip 10 can be at least two times greaterthan the diameter of the suture tape with which the strip is associatedin some instances. A person skilled in the art will recognize that theratio of the width of a tissue augmentation strip to diameter of thefilament or related structure with which the strip is used can be anysuitable ratio, depending, at least in part, on the type of filament orrelated structure being used, the type of strip or other construct beingused, and the type of procedure being performed, and thus a ratio ofwidth to diameter may be smaller or larger than those provided forherein. Further, in some embodiments a ratio of the width L of the strip10 to the width W of the strip 10 can be approximately in the range ofabout 2:1 to about 20:1, and more particularly the length L can be atleast three times greater than the width Win some instances, at leastfive times greater in some other instances, and at least ten timesgreater in some instances, although other L-W ratios are possible. Stillfurther, the strip 10 can be substantially flat and approximatelyuniform. In some embodiments a ratio of the width W of the strip 10 tothe thickness T of the strip 10 can be approximately in the range ofabout 2:1 to about 20:1, and more particularly the width W can be atleast three times greater than the thickness T in some instances, atleast five times greater in some other instances, and at least ten timesgreater in some instances, although other W-T ratios are possible. Avariety of other sizes and shapes of the tissue augmentation tape strip10, including ratios of the dimensions of the tissue augmentation stripand associated components (e.g., the suture limb 12 a) can be utilizedwithout departing from the spirit of the present disclosure.

While ratios can be useful to help describe the relationship between thestrip 10 and the filament limb 12 a, and the relationship between thedimensions of the strip 10, some exemplary, non-limiting dimensions fora tissue augmentation strip can also be useful in understanding thepresent disclosure. As mentioned above, these dimensions can bedependent on a variety of factors. In some embodiments, the length L cancover a significant portion, to almost an entire portion, of a length oftissue extending between a stitch made in tissue and a bone anchor usedto help secure the tissue. In some embodiments, the length L can beapproximately in the range of about 5 millimeters to about 1 centimeter,the width W can be approximately in the range of about 1 millimeter toabout 5 millimeters, and the thickness T can be approximately in therange of about 0.5 millimeter to about 3 centimeters. Further, while thestrip 10 is described as having a length, width, and thickness, and itis shown as being substantially flat in FIG. 1A, FIG. 1B illustratesthat the strip 10 can be relatively flexible, for instance it can bebunched in portions by the suture limb 12 passing therethrough.Materials used to form the strip 10 are described in a later section ofthe present disclosure.

A number of techniques can be used to associate the tissue augmentationstrip 10 with the suture limb 12 a. As shown in FIG. 1B, the suture limb12 a is threaded from a top side 10 a to a bottom side 10 b and back tothe top side 10 a of the tissue augmentation strip 10. The process ofthreading the suture limb 12 a through the tissue augmentation strip 10can be repeated as many times as desired. In some embodiments a suturethreader can be threaded through the tissue augmentation strip 10 aheadof a procedure so that the operative suture can be threaded through thetissue augmentation strip in vivo during the procedure. Exemplary suturethreaders are discussed below with regards to alternative tissueaugmentation constructs.

While the tissue augmentation strip 10 of FIG. 1B is shown having anexaggerated, wave-like profile when engaged with the suture limb 12 a,in practice the tissue augmentation strip 10 can conform to the geometryof the soft tissue that it is contacting. By including the tissueaugmentation strip 10 on the suture limb 12 a, the suture limb 12 a hasa broader foot print, thus covering more surface area of the tissue.Further the tissue augmentation strip 10 may allow force applied to thetissue by the suture limb 12 a to be distributed over a larger amount ofsurface area. The larger amount can be dependent on the surface area ofthe tissue augmentation strip 10. Thus, in embodiments where the widthof the tissue augmentation strip 10 is at least three times greater thanthe diameter of the suture limb 12 a, the force of the suture limb 12 aon the tissue may be distributed over an area that is at least threetimes greater than would otherwise be if no tissue augmentation strip 10was associated with the suture limb 12 a. The increased tissue surfacearea coverage and distributed force of the tissue augmentation strip 10may result in a reduced pressure peak on the soft tissue. In use, it iseither the surface 10 a or the surface 10 b that engages the tissue andmay allow for the increased distribution. Where the soft tissue hasbecome degenerated due to injury or age, a reduction in pressure canresult in less chance of abrasion of the tissue. Further, the broadertissue coverage may enhance healing of otherwise compromised tissue.

The suture limb 12 a used in conjunction with the tissue augmentationstrip 10 can be any type of suture (e.g., braided filament, cannulatedfilament, mono filament, suture tape, etc.) and can have a size betweenabout a #5 filament (about 20 gauge to about 21 gauge) and about a #3-0filament (about 29 gauge to about 32 gauge). A person skilled in the artwill recognize a variety of other filament types and sizes that can alsobe used in conjunction with the augmentation strip 10, such as, if asuture tape is used.

Tissue Augmentation Constructs—Tissue Augmentation Constructs Having aCannulated Portion

Another exemplary embodiment of a tissue augmentation construct, asshown a tissue augmentation block 110, is provided for in FIGS. 2A-2D.Alternatively, tissue augmentation constructs, like block 110, can bereferred to generally as tissue augmentation constructs having acannulated body. Tissue augmentation constructs having a cannulated bodycan include the tube 110, bars 3010, 3010′, and washers 310, 410. In oneexemplary embodiment of augmentation blocks, the blocks can be acannulated tube configured to be disposed on or otherwise associatedwith a suture limb 112 a. More particularly, the augmentation tube 110can have a substantially cylindrical, or ovoid, body with a bore orlumen 114 extending therethrough from a proximal-most end 110 p to adistal-most end 110 d. To the extent the block 110 is described as atube, such description in no way limits the configuration of the tissueaugmentation blocks to being tubes or having a tubular construction. Atube-like configuration is one of a variety of configurations of blocksprovided for herein or otherwise derivable herefrom. Other non-limitingembodiments of blocks include but are not limited to bars and washers,as further described below.

Turning back to the cannulated nature of the block 110, the bore 114 canbe used, for example, to receive the suture limb 112 a so that the block110 and limb 112 a can be associated with each other, as described ingreater detail below. As shown, the block 110 has a length L′ that isgreater than a diameter D, and in many instances substantially greater.Further, the diameter D can be greater than a diameter of a filament orsuture with which the tissue augmentation block 110 is associated, e.g.,the suture limb 112 a, thereby increasing the surface area of tissueaugmentation of the system or device used in the surgical repair.

A person skilled in the art will recognize that the dimensions of thelength L′ and diameter D of the tissue augmentation tube 110, as well asa diameter d of the bore 114, can depend on a variety of factors,including but not limited to the size of the filament with which it isto be associated, the anatomy of the patient, and the type of procedurebeing performed. In some embodiments a ratio of the length L′ and thediameter D can be approximately in the range of about 2:1 to about 20:1,and more particularly the length L′ can be at least three times greaterthan the diameter D in some instances. Further, in some embodiments aratio of the diameter D of the tube 110 to a diameter of the suture limb112 a can be approximately in the range of about 2:1 to about 20:1, andmore particularly the diameter D can be at least three times greaterthan the diameter of the filament or suture with which the tissueaugmentation tube 110 is associated in some instances. A variety ofother sizes and shapes of the tissue augmentation tube 110, includingratios of the dimensions of the tissue augmentation block and associatedcomponents (e.g., the suture limb 112 a) can be utilized withoutdeparting from the spirit of the present disclosure.

While ratios can be useful to help describe the relationship between thetube 110 and the filament limb 112 a, and the relationship between thedimensions of the tube 110, some exemplary, non-limiting dimensions fora tissue augmentation tube can also be useful in understanding thepresent disclosure. As mentioned above, these dimensions can bedependent on a variety of factors. In some embodiments, the length L′can cover a significant portion, to almost an entire portion, of alength of tissue extending between a stitch made in tissue and a boneanchor used to help secure the tissue. In some embodiments, the lengthL′ can be approximately in the range of about 5 millimeters to about 2centimeter, and the diameter D can be approximately in the range ofabout 1 millimeter to about 5 millimeters. The size of the diameter d ofthe bore 114 can also depend on a variety of factors, including but notlimited to the size of the limb to be passed therethrough. In someembodiments, the diameter d can be approximately in the range of about0.75 millimeters to about 3 millimeters.

Alternative embodiments of tissue augmentation blocks 110 havingcannulated portions are shown in FIGS. 2E, 2F, 2G, 2H, and 2I. Not alltissue augmentation blocks have cannulated portions, although that is acommon feature of the blocks 110, 3010, 3110, 2810 a, 2810′, 2810″provided for in FIGS. 2A-2I. Other configurations of tissue augmentationblocks do not have cannulated portions, or cannulated portions throughwhich sutures limbs are passed, and thus other configurations can beassociated with limbs using other techniques provided for hereinotherwise known to those skilled in the art.

As discussed above, and shown in FIGS. 2E and 2F, tissue augmentationbars 3010, 3110 can have a rectangular and/or square cross sectionalshape. Other cross sectional shapes are possible and include, forexample, triangular, quadrilaterals, pentagons, hexagons, octagons, etc.As shown in FIG. 2E, cannulated bar 3010 is configured to be disposed onor otherwise associated with a suture limb, as described above withrespect to the cannulated tube 110. More particularly, the bar 3010 canhave a substantially rectangular body with a rectangular bore or lumen3014 extending therethrough from a proximal-most end 3010 p to adistal-most end 3010 d. The bore 3014 can be used, for example, toreceive the suture limb so that the bar 3010 and suture limb can beassociated with each other, as described in greater detail below. It iscontemplated that bore 3014 can be created through manufacturingtechniques discussed below with respect to augmentation block 110.

An alternative construction of tissue augmentation bar 3010, tissueaugmentation bar 3110, is shown in FIG. 2F. As shown in FIG. 2F, thecannulated bar 3110 is configured to be disposed on or otherwiseassociated with a suture limb, as described above with respect to thecannulated blocks 110, 3110. More particularly, the bar 3110 can have asubstantially rectangular body with a rectangular bore or lumen 3114extending therethrough from a proximal-most end 3110 p to a distal-mostend 3110 d. The bore 3114 can be used, for example, to receive thesuture limb so that the bar 3110 and suture limb can be associated witheach other, as described in greater detail below. As shown, bar 3110 canbe constructed of two portions of material, 3110 a, 3110 b. The twopieces of material 3110 a, 3110 b can be associated with each other bymeans of sutures 3124 a, 3124 b. The pieces of material 3110 a, 3110 bcan be attached to each other such that lumen 3114 is formed using anymanufacturing techniques discussed throughout the present disclosure. Avariety of other sizes and shapes of the bars 3010, 3110 includingratios of the dimensions of the bar and associated components (e.g., thesuture limb) can be utilized without departing from the spirit of thepresent disclosure.

Further alternative configurations of tissue augmentation blocks 2810 a,2810′, and 2810″ are illustrated in FIGS. 2G, 2H, and 2I, respectively.As shown, the cannulated blocks 2810 a, 2810′, 2810″ can all besubstantially the same as tissue augmentation block 110, as shown inFIGS. 2A-2D. Alternatively, the cannulated blocks 2810 a, 2810′, 2810″can have configurations substantially similar to the tissue augmentationbars 3010, 3110. The cannulated blocks 2810 a, 2810′, 2810″ can have alength that is substantially longer than the tissue augmentation blocks110. In one exemplary embodiment, the block 2810 a can have a lengthapproximately in the range of about 15.0 millimeters to about 25.0millimeters. Advantageously, blocks 2810 a, 2810′, 2810″ can have alength that can extend from lateral anchors medially up and over a softtissue repair to provide for additional protection for the repair andadditional scaffolding to aid in healing.

A number of techniques can be used to associate the tissue augmentationblocks 110, 3010, 3110, 2810 a, 2810′, 2810″ with a suture limb 112 a.For example, as shown in FIG. 2A, the suture limb 112 a is threaded orpassed from the proximal-most end 110 p to the distal-most end 110 d ofthe tissue augmentation tube 110 without passing through, that isacross, the body of the tube 110. In other words, the suture limb 112 adoes not pass into a sidewall of the body that defines the lumen 114. Assuch, the tube 110 is not coupled or attached to the suture limb 112 a,and instead can freely pass along a length of the limb 112 a unhinderedor unrestricted. In other embodiments, the limb 112 a can pass through,that is across, the body once or more to further secure a location ofthe tube 110 with respect to the limb 112 a, thereby coupling orattaching the tube 110 to the suture limb 112 a. A person skilled in theart will recognize a variety of other ways by which the tube 110 can beassociated or coupled with the limb 112 a without departing from thespirit of the present disclosure.

The tissue augmentation tube 110 can be threaded by hand on to thesuture limb 112 a, either at the surgical site, or outside of the body.Alternatively, as shown in FIGS. 2B and 2C, the tissue augmentation tube110 can have a threader 206 inserted through the bore 114 prior to thetissue augmentation tube 110 being threaded onto the suture limb 112 a.The threader 206 can include a proximal handle portion 208, anintermediate elongate portion 210, and a distal suture-receiving end212. The proximal handle portion 208 can be configured to be easilygripped by a user, for instance by having a substantially rectangularshape as shown. Other shapes and features for gripping can be provided.The intermediate portion can be a filament portion 210 capable of havinga tissue augmentation construct, e.g., the tissue augmentation tube 110,associated therewith, thereby allowing the threader 206 to be flexible.The distal suture-receiving end 212 can have a distal opening 212through which a suture to be associated with a augmentation strip, e.g.,suture limb 112 a, can be disposed. In the illustrated embodiment, thedistal opening 212 is flexible and, in some embodiments, can be made ofa wire, a fiber, a thread, a cord, and/or other flexible structure orother material having similar characteristics. Because the distalopening 212 is flexible, it can change shape before, during, and afteruse, and thus while in the illustrated embodiment it has a diamond orkite-shape, other configurations are possible. Further, the flexiblenature of the opening 212 can allow the opening 212 to collapse around asuture disposed therein to strangulate or otherwise hold the sutureduring use. In some embodiments, the intermediate portion 210 can alsobe made of a wire, a fiber, a thread, a cord, and/or other flexiblestructure. The term wire is not intended to imply that the structure ismade of metal, or has metal characteristics, but the intermediateportion 210 and the distal suture-receiving end 212 can be made ofmetal.

FIGS. 2G-2I provide for additional configurations of suture limbs beingassociated with tissue augmentation constructs. As shown in FIG. 2G, theconstruct 2810 a can include two threaders disposed therethrough forassociating the construct 2810 a with at least one suture limb. Asillustrated in FIG. 2G, a first threader 2809 a can be disposed throughthe block 2810 a from a top surface 2811 t to a bottom surface 2811 asuch that the handle 2808 a is proximate the top surface 2811 t and thereceiving end 2807 b is proximate the bottom surface 2811 b. The firstthreader 2809 a can be disposed through the block 2810 a such that itintersects the central lumen 2870 of the block 2810 a substantiallyperpendicularly relative thereto. Alternatively, the threader 2809 a canbe disposed at any angle relative to the central lumen 2870. The firstthreader 2809 a can be disposed at the proximal end 2811 p, or proximalhalf, of the block 2810 a. A second threader 2809 b can be disposedthrough a distal portion 2811 d of the block 2810 a. For example thesecond threader 2809 b can extend from a distal end 2811 d of the block2810 a through the lumen 2870 to a medial location 2870 m of the lumenand out of the bottom 2811 b of the block 2810 a. In one exemplaryembodiment the second threader 2809 b can extend through the block 2810a such that a handle portion 2808 b of the threader 2809 b is proximatethe distal end 2811 d of the block 2810 a and the receiving end 2807 bof the threader extends out the bottom 2811 b of the block 2810 a.Alternatively, other suture threader configurations are contemplated asshown in FIGS. 2H and 21 and discussed below.

In one alternative suture threader configuration, as shown in FIG. 21,block 2810′ can include a pre-threaded suture 2814′ in the proximal end2811 p′ of the block, obviating the need for a second threader. Thepre-threaded suture 2814′ can be threaded into block 2810′ at a locationthat is substantially similar to the second threader 2809 b of FIG. 2G.The pre-threaded suture 2014′ can be threaded into the block 2810′either before or after the block is associated with a repair suture, notshown. In a further alternative configuration, as shown in FIG. 2H,block 2810″ can include two threaders 2809 a″ and 2809 b″. The threaders2809 a″, 2809 b″ can be substantially similar to threaders 2809 a, 2809b discussed above. As shown, the second threader 2809 b″ can be disposedthrough a central lumen 2870″, for example from the proximal terminalend 2811 p″ to the distal terminal end 2811 d″. Alternatively, thesecond threader 2809 b″ can extend through any length of the centrallumen 2870″. The second threader 2809 b″ can associate suture limbs, notshown, with the block 2810″ using techniques provided for throughout thepresent disclosure. The suture limbs can each exit the block 2810″ atthe distal end 2811 d″ along with a repair suture limb to besubsequently anchored into the bone at a location laterally offset fromthe soft tissue repair.

In use, a force P₁ can be applied to the handle portion 208 to move thefilament portion 210 and the distal opening 212 in the direction of theforce P₁ with respect to the augmentation tube 110. The distal opening212, and thus the suture limb 112 a coupled thereto, can be drawn intoand through the augmentation tube 110 by way of this movement, thusdisposing the augmentation tube 110 onto the suture limb 112 a. As thedistal opening 212 enters the augmentation tube 110, the opening 212 canbe collapsed, e.g., compressed to a smaller width, around the suturelimb 112 a to strangulate the limb 112 a, thus making it easier for thesuture limb 112 a to be drawn into a body of the augmentation tube 110.Once the augmentation tube 110 is disposed on or is otherwise associatedwith the suture limb 112 a, the suture limb 112 a can be disassociatedwith the distal opening 212 and the threader 206 can be discarded orreused since it is no longer associated with either the augmentationtube 110 or the suture limb 112 a. The combination of the suture limb112 a and the augmentation tube 110 can then be used in a variety ofprocedures, as detailed further below. The process of disposing theaugmentation tube 110 onto the suture limb 112 a can occur outside ofthe body or inside the body, including proximate to the surgical site.

Similar to the tissue augmentation strip 10, by including the tissueaugmentation tube 110 on the suture limb 112 a, the suture limb 112 ahas a broader footprint, thus covering more surface area of the tissue.Further, the tube 110 may allow force applied to the tissue by thesuture limb 112 a to be distributed over a larger amount of surfacearea. The larger amount can be dependent on the surface area of thetissue augmentation tube 110. Thus, in embodiments where the diameter ofthe tissue augmentation tube 110 is at least three times greater thanthe diameter of the suture limb 112 a, the force of the suture limb 112a on the tissue may be distributed over an area that is at least threetimes greater than would otherwise be if no tissue augmentation tube 110was associated with the suture limb 112 a. The increased tissue surfacearea coverage and distributed force of the tissue augmentation tube 110may result in a reduced pressure peak on the soft tissue. Where the softtissue has become degenerated due to injury or age, an increased tissuesurface area coverage and a reduction in pressure can result in lesschance of abrasion of the tissue. Further, the broader tissue coveragemay enhance healing of otherwise compromised tissue and/or provide bulkto otherwise compromised or degenerate tissue and/or tendon.

Threaders like the threader 206 can also be used in conjunction with aninstallation tool to assist in associating an augmentation constructwith a suture. FIG. 3 provides for a threader 206′ that is similar tothe threader 206 except that the proximal handle portion 208′ and distalreceiving end 212′ have a slightly different shape. As shown, theproximal handle portion 208′ is in the form of a gripping protrusion208′ that has a diameter that is greater than a diameter of theintermediate filament portion 210′, thus allowing a user to easily gripthe proximal handle portion 208′. A person skilled in the art willrecognize that the proximal handle portion 208′ can have most any shape.Likewise, a shape of the distal receiving end 212′ can also have mostany shape. In the illustrated embodiment, the distal receiving end 212′is a distal opening 212′, but the opening is illustrated as being morerounded than the distal opening 212. However, as explained above,because the distal opening 212′ can be flexible, even the illustratedembodiments can be manipulated into other shapes.

The installation tool 200′ can include a handle portion 202′ and acartridge portion 204′. The handle portion 202′ can be long such thatthe installation tool 200′ can be inserted through a cannula into asurgical site inside of the body. Alternatively, the handle portion 202′can be any suitable length. As shown in FIG. 3, the handle 202′ includesa proximate portion 202 p′ and a distal portion 202 d′. The distalportion 202 d′ of the handle 202′ can be angularly offset from theproximal portion 202 p′ to allow for the cartridge 204′ to be orientedin a favorable orientation to thread the augmentation tube 110′ onto thelimb 112 a′. Alternatively, the proximal portion 202 p′ and the distalportion 202 d′ can be in line with each other.

The distal portion 202 d′ can be attached to a cartridge 204′ that issized to receive an augmentation tube 110′ to be threaded onto suturelimb 112 a′. The cartridge 204′ can be cylindrical in shape, having anapproximately circular cross section. Alternatively, the cartridge 204′can have a triangular, rectangular, or any other shape and/or crosssection. The cartridge 204′ can have a lumen 214′ extending therethroughfrom a first opening 216′ to a second opening 218′. The first opening216′ can be larger than the second opening 218′. Alternatively, thefirst opening 216′ and the second opening 218′ can be any desired size.As shown in FIG. 3, the first opening 216′ can have a diameter that issubstantially the same as the lumen 214′ such that the augmentation tube110′ can be placed therethrough. The second opening 218′ can have adiameter that is sized to receive a relevant portion of the threader206′ therethrough.

As shown in FIG. 3, a suture limb 112 a′ is inserted through the opening212′ and the threader 206′ can be operated in a manner similar to thethreader 206 to dispose the augmentation tube 110′ onto the suture limb112 a′. For example, an operator can grasp the handle portion 208′ ofthe threader 206′ to pull the opening 212′ through the cannula 114′ ofthe augmentation tube 110′ by the application of a force F_(P)′. Thehandle 208′ can be pulled until the entirety of the threader 206′ and adistal portion of the suture limb 112 a′ have passed through the secondopening 218′. Once the suture limb 112 a′ has been threaded through theaugmentation tube 110′, the threaders 206′ can be discarded or reusedand the installation tool can release the augmentation tube 110′ byactuation of a release mechanism (not shown). Alternatively, theaugmentation tube 110′ can be held in the cartridge 204′ with aninterference fit, such that no release mechanism is required. Whilereference is made to augmentation tube 110′ and suture limb 112 a′, asnoted above, the installation tool 200′ can be used in the same mannerwith augmentation strip 10 of FIGS. 1A-1B, as well as other constructsprovided for herein. Further, while threaders are discussed as beingused in conjunction with an installation tool, the threader itself canbe considered an installation tool since embodiments provided for hereinallow the threader to be used to associate a suture with a augmentationconstruct without using the installation tool 200′.

Tissue Augmentation Constructs—Tissue Augmentation Blocks Having aWasher, Disc, or Ring Configuration

An exemplary embodiment of a tissue augmentation construct, as shown atissue augmentation block 310, is provided for in FIG. 4. Theaugmentation block 310 has a configuration that can be described as awasher, disc, or ring, and the illustrated embodiment it is asquare-shaped washer configured to be disposed on or otherwiseassociated with a suture limb 312 a. For example, the washer 310 canhave a substantially rectangular prism-shaped body with a bore or lumen314 extending therethrough from a proximal-most end 310 p to adistal-most end 310 d. The bore 314 can be used, for example, to receivethe suture limb 312 a so that the washer 310 and limb 312 a can beassociated with each other, as described in greater detail below. Asshown, the washer 310 has a length L_(B) and a width W_(B) which aresubstantially equal, and height T_(B) which is less than the lengthL_(B) and the width W_(B). Alternatively, the washer 310 can have a moreelongated rectangular shape having a length L_(B) that is larger thanthe width W_(B). In a further alternative, the length L_(B), widthW_(B), and the height T_(B) can be substantially equal, thereby forminga cube-shaped body. Further, the diameter d_(B) of the lumen can begreater than a diameter of a filament or suture with which the washer310 is associated, e.g., the suture limb 312 a. In other embodiments thesuture limb 312 a can be threaded through the washer 310 without apreformed lumen. Once the block is associated with the suture limb 312a, the block can increase the surface area of compression of the systemor device used in the surgical repair due to the increased surface areaof the block.

A person skilled in the art will recognize that the dimensions of thelength L_(B), width W_(B), thickness or height T_(B), and diameter d_(B)of the washer 310 can depend on a variety of factors, including but notlimited to the size of the filament with which it is to be associated,the anatomy of the patient, and the type of procedure being performed.In some embodiments, the washer 310 can have a length L_(B)approximately in the range of about 3 millimeters to about 6millimeters, a width W_(B) in the range of about 3 millimeters to about6 millimeters, and thickness or height T_(B) approximately in the rangeof about 1 millimeter to about 3 millimeters. Alternatively, the lengthL_(B), width W_(B), and thickness or height T_(B) can all besubstantially equal and have a dimension approximately in the range ofabout 2 millimeters to about 5 millimeters. One benefit to the smallerdimensions of the washer 310 is that a surgeon can load a plurality ofthe washers 310 onto a single suture limb, as described further below,to allow for precision application of the washers on areas of thedamaged tissue where they are required. For example, precisionapplication of the washers can include moving the washers along a lengthof a suture limb to more precisely direct where force from the suturelimb will be distributed across a greater surface area. In view of thepresent disclosures, it is clear that the thickness or height of thewashers 310 can be substantially less than a length of suture limb onwhich the washers 310 are disposed. Any number of washers 310 can bedisposed on the suture limb, including but not limited to up to 30. Insome exemplary embodiments, the number of washers 310 provided on asingle suture limb is approximately in the range of about 2 blocks toabout 8 blocks.

An alternative embodiment of an augmentation construct configured to beeffectively used in conjunction with other similarly sized constructs onthe same suture limb is illustrated in FIG. 5. As shown, the tissueaugmentation construct is a tissue augmentation block 410 that has aconfiguration that can be described as a washer, disc, or ring. In theillustrated embodiment, it is a ring or circular-shaped washer. Forexample, the tissue augmentation washer 410 can have a bore or lumen 414extending therethrough from a proximal-most face 410 p to a distal-mostface 410 d. The bore 414 can be used, for example, to receive the suturelimb 412 a so that the washer 410 and limb 412 a can be associated witheach other, or alternatively, the limb 412 a can be associated with thewasher 410 by threading it through the body of the ring without anypreformed hole or bore.

A person skilled in the art will recognize that the dimensions of thediameter D_(W), height H_(W), and bore diameter d_(W) of the washer 410can depend on a variety of factors, including but not limited to thesize of the filament with which it is to be associated, the anatomy ofthe patient, and the type of procedure being performed. In someembodiments, the diameter D_(W) can be approximately in the range ofabout 3 millimeters to about 6 millimeters, height H_(W) can beapproximately in the range of about 1 millimeter to about 3 millimeters,and bore diameter d_(W) can be approximately in the range of about 0.5millimeters to about 2 millimeters. Similar to the washer 310, in viewof the present disclosures, it is clear that the thickness or height ofthe washer 310 can be substantially less than a length of suture limb onwhich the washers 410 are disposed. Any number of washers 410 can bedisposed on the suture limb, including but not limited to up to 30. Insome exemplary embodiments, the number of washers 410 provided on asingle suture limb is approximately in the range of about 2 washers toabout 8 washers.

One benefit of the washers 310, 410 is that a surgeon can pass bothanterior and posterior sutures through the washers 310, 410, asdescribed further below, at the suture insertion point to prevent cheesewiring at the suture insertion point by the sutures. Further, thewashers 310, 410, can be used in conjunction with any of the tissueaugmentation constructs disclosed, including by disposing one or morewashers 310, 410 onto the same suture limb on which another tissueaugmentation construct is already, or will be, disposed.

A number of techniques known to those skilled in the art can be used toassociate the washers 310, 410 with the respective suture limbs 312 a,412 a. The suture limb 312 a, 412 a can be threaded or passed from theproximal-most end 310 p, 410 p to the distal-most end 310 d, 410 d ofthe washers 310 or 410 without passing into and/or through the body ofthe washers 310, or 410, i.e., the suture limb 312 a, 412 a extendsdirectly through the lumen 314, 414. Thus, like the tube 110, thewashers 310, 410 can freely pass along a length of the suture limb 312a, 412 a unhindered or unrestricted since they are not coupled orattached to the suture limb 312 a, 412 a. In other embodiments, the limb312 a, 412 a can pass through the body once or more to further secure alocation of the washers 310 410 with respect to the limb 312 a, 412 a. Aperson skilled in the art will recognize a variety of other ways bywhich the washers 310, 410 can be associated with the limbs 312 a, 412 awithout departing from the spirit of the present disclosure. Forexample, the washers 310 or 410 can be threaded by hand on to the suturelimb 312 a, 412 a either at the surgical site, or outside of the body.Alternatively, one or more washers 310 or 410 can have a threader (notshown) inserted through the respective bores 314, 414 prior to thewashers 310 or 410 being threaded onto the suture limb 312 a, 412 a. Thethreader can be the same or similar to the threaders 206, 206′ describedabove and can be used to thread a suture limb 312 a, 412 a through thewasher 310 or 410 at a surgical site.

Similar to augmentation blocks 10, 110, by including either, or both of,the washers 310 or 410 on a suture limb, force applied to the tissue bythe suture limb is distributed over a larger amount of surface area. Thelarger amount is dependent on the surface area of the augmentationwasher 310 or 410, as well as the number of washers used.

Materials for Forming Augmentation Constructs

The constructs discussed above, e.g., the blocks 10, 110, 3010, 3110,310, and 410, as well as those provided for further below (includingvarious patches or scaffolds) can be made of one or more biocompatible,bioresorbable materials so that after implantation into a patient toreplace or repair connective tissue, the strip gradually degrades orremodels over time. The resorption profile of the constructs can besufficiently long to reinforce and provide structure to tissue duringthe regeneration or healing process. A person skilled in the art candetermine a suitable resorption profile, depending, at least in part, onthe desired use of the construct, and can tailor the resorption profileby varying the materials used to form the construct.

While many different materials can be used to form the tissueaugmentation constructs, either alone or in combination with othermaterials, in some instances the material is a biocompatible polymer.Exemplary embodiments of suitable biocompatible materials syntheticpolymers, natural polymers, and combinations of the two. As used herein,the term “synthetic polymer” refers to polymers that are not found innature, even if the polymers are made from naturally occurringbiomaterials. As used herein, the term “natural polymer” refers topolymers that are naturally occurring. In embodiments where the tissueaugmentation constructs includes at least one synthetic polymer,suitable biocompatible synthetic polymers can include polymers selectedfrom the group that includes aliphatic polyesters, poly(amino acids),copoly(ether-esters), polyalkylene oxalates, polyamides, tyrosinederived polycarbonates, poly(iminocarbonates), polyorthoesters,polyoxaesters, polyamidoesters, polyoxaesters containing amine groups,poly(anhydrides), polyphosphazenes, polyurethanes, poly(etherurethanes), poly(ester urethanes), poly(propylene fumarate),poly(hydroxyalkanoate), polydioxanone,poly-hydroxybutyrate-co-hydroxyvalerate, polyamniocarbonate,polytrimethylene, polyoxaamides, elastomeric copolymers, andcombinations or blends thereof. Suitable synthetic polymers for use inthe tissue augmentation constructs can also include biosyntheticpolymers based on sequences found in collagen, a collagen scaffold,pulverized collagen pieces, elastin, thrombin, silk, keratin,fibronectin, starches, poly(amino acid), gelatin, alginate, pectin,fibrin, oxidized cellulose, chitin, chitosan, tropoelastin, hyaluronicacid, ribonucleic acids, deoxyribonucleic acids, polypeptides, proteins,polysaccharides, polynucleotides, and combinations or blends thereof.The types of materials that can be used to construct tissue augmentationconstructs, either wholly or in part, include non-absorbable polymersselected from the group that includes, but is not limited to,polyethylene, polypropylene, polyetheretherketone (PEEK),polytetrafluoroethylene, silicone, rubber, or other biocompatiblenon-absorbable polymers, and combinations thereof. Natural polymers forthe use in augmentation strip 10 can be selected from the group thatincludes but is not limited to a fibrin-based material, collagen-basedmaterial, a hyaluronic acid-based material, a cellulose-based material,a silk-based material, a gelatin-based material, a glycoprotein-basedmaterial, a cellulose-based material, a polysaccharide-based material, aprotein-based material, a fibronectin-based material, a chitin-basedmaterial, a pectin-based material, an elastin-based material, analginate based material, a dextran-based material, an albumin-basedmaterial, a natural poly(amino acids) based material, a decellularizedtissue, purified extracellular matrix (ECM), a demineralized bonematrix, and combinations thereof.

Still further, virtually any type of tissue can be used to form thetissue augmentation constructs, including but not limited to autografttissue and allograft tissue, as well as human allogeneic tissue andxenogeneic tissue, which includes porcine, bovine, and equine amongothers. The tissue used can be selected from biological connectivetissues that include ligament tissue, tendon tissue, a modeled tendon,skin tissue, muscle tissue, periosteal tissue, pericardial tissue,synovial tissue, dermal tissue, an acellular porcine dermal matrix, anacellular bovine dermal matrix, fascia, small intestine tissue,embryonic tissue, amniotic tissue, placental tissue, periodontal tissue,peritoneum tissue, vascular tissue, blood, and combinations thereof. Thematerials used to form the tissue augmentation constructs can becross-linked and non-crosslinked, and any material provided for hereincan be used in conjunction with other materials, whether synthetic,natural, or a combination thereof. Still further, the tissueaugmentation constructs, and/or materials used to form the tissueaugmentation constructs, can be treated with platelet-rich plasma (PRP),bone marrow, cells, and other bone and/or tissue growth-promotingmaterials.

The material used to form the tissue augmentation constructs can be madeand/or formed, using a variety of techniques. These techniques include,but are not limited to, knitting them and weaving them. The overallconstruction of the materials can be described as being woven, knitted,non-woven, and/or a foam, among other constructions resulting fromtechniques known to a person skilled in the art. Further, a combinationof techniques can be used for a single construct, and/or a portionthereof. The formation techniques can be used with materials, e.g.,synthetic polymers and other materials provided for above, as well astissue.

Tissue Augmentation Kits

The filaments and tissue augmentation constructs provided for herein canbe included together as part of a soft tissue repair kit. Such a kit canalso include components such as a threader, installation tool, boneanchors, and/or a bone drill. For example, one exemplary embodiment of akit can include one or more tissue augmentation constructs and one ormore threaders. In some instances, the tissue augmentation constructscan be pre-disposed on the threaders. The tissue augmentation constructscan include any of the constructs provided for herein or otherwisederivable from the present disclosures, including but not limited to thetissue augmentation blocks 10, 110, 3010, 3110, 310, 410 and the tissueaugmentation patches 2210, 2310, 2410, and 2510, which are describedbelow. The threaders can include the threaders 206, 206′, as well asother threaders known to those skilled in the art or otherwise derivablefrom the present disclosures. In instances where tissue augmentationconstructs are pre-disposed on the threader, the constructs can bedisposed on the intermediate portion 208, 208′ of the threaders 206,206′.

The kit can also include other components used in conjunction withtissue augmentation constructs and threaders, including but not limitedto one or more sutures, such as the sutures 12 a, 112 a, one or moreinstallation tools, such as the installation tool 200′, one or moreimplants, e.g., bone anchors, and one or more bone drills. In someexemplary embodiments the kit can include a tissue augmentation block10, 110, 3010, 3110, 310, 410 for every suture limb 12 a, 112 a, 312 a,412 a that will be anchored over the soft tissue. The types andconfigurations of the filaments, constructs, installation tools (whichcan include threaders as stand-alone installation tools), and boneanchors can be varied, thus providing the user options for use in anysurgical procedure. Accordingly, any combination of blocks having astrip or tape configuration (e.g., strip 10), a cannulated tubeconfiguration (e.g., tube 110), a cannulated bar configuration (e.g.,bar 3010, bar 3110), and a washer configuration (e.g., washer 310,washer 410), can be mixed and matched by a surgeon, as desired,including by disposing them on the same suture limb. The selection ofconstructs to be used can depend, at least in part on a variety offactors, including but not limited to the size of the filament withwhich it is to be associated, the anatomy of the patient, and the typeof procedure being performed.

The threader and/or installation tool can be a single device used toassociate tissue augmentation constructs to limbs multiple times, ormultiple threaders and tools can be provided to allow multiplestrip-limb combinations to be formed or to allow for differentconfigurations preferred by different users. The threader and/orinstallation tool can be specifically adapted to be used with particulartissue augmentation constructs, procedures, and/or surgeon's preferenceswithout departing from the spirit of the present disclosure.

To the extent implants such as anchors are provided as part of a kit, orused in conjunction with any of the disclosures provided for herein, theimplants can be any type of implant known to those skilled in the artthat are used for various types of tissue repair procedures. For boneanchors, the anchors can be of a hard construction or a softconstruction, and in some instances they can be knotless anchors,meaning filaments associated therewith do not need to have knots tied bythe surgeon during the surgical procedure to couple the tissue to thefilament and/or the anchor. Some exemplary embodiments of hard sutureanchors for use in the kits or more generally with the presentdisclosures include Healix Ti™ anchors that are commercially availablefrom DePuy Synthes, as well as Healix Advance™ anchors, Helix AdvanceKnotless™ anchors, Healix BR™ anchors, Healix PEEK™ anchors, HealixTranstend™ anchors, Bioknotless® anchors, Gryphon® anchors, Fastin®anchors, Versalok® anchors, Microfix® anchors, Minilok™ anchors,MicroQuickanchors® anchors, and Tacit® anchors, each of which is alsocommercially available from DePuy Mitek, Inc. Some exemplary embodimentsof soft suture anchors for use in the kits or more generally with thepresent disclosures include those described in U.S. Pat. No. 9,345,567of Sengun, the content of which is incorporated by reference herein inits entirety.

To the extent the kit includes a bone drill, any type of bone drillknown by those having skill in the art for forming bone holes in whichanchors can be disposed can be provided.

Methods of Use—Rotator Cuff Repairs

Exemplary methods for using systems, devices, and kits of the typedescribed herein are now described in greater detail. While the methodsdescribed herein generally relate to attaching soft tissue to bone, andin this section of the disclosure are primarily discussed with respectto rotator cuff repairs, a person skilled in the art will recognizeother types of procedures and repairs with which the constructs and themethods related to the same can be used. Further, to the extent aparticular type of tissue augmentation construct is illustrated in thefollowing embodiments, a person skilled in the art would understand howto employ other tissue augmentation constructs provided for hereinwithout departing from the spirit of the present disclosures. Likewise,any sutures or anchors provided for herein or otherwise known to thosehaving skill in the art can be used, including knotless anchors. Stillfurther, while in the illustrated embodiments the lengths of sutures andlimbs may be approximately equal, any suture or limb can be any desiredlength, and thus lengths of sutures and limbs do not need to be equal.Likewise, to the extent the techniques described below discuss having acertain number of suture limbs (e.g., one, two, three, etc.) extendingfrom or otherwise associated with a suture anchor to perform the tissuerepair, a person skilled in the art, in view of the present disclosures,will understand how a different number of limbs can be used to performthe same, or a similar type, of repair. A benefit that results from eachof the methods described herein is that the tissue augmentationconstructs can be associated with the suture being used in the repair inan on-demand manner, thus allowing a surgeon to quickly and easilyassociate one or more tissue augmentation constructs with the repairsuture(s) to form desired footprints for the repair.

Rotator Cuff Repairs—Double Row Applications

A first exemplary method of soft tissue repair using tissue augmentationblocks 110, illustrated as blocks 110 a, 110 b, in conjunction with adouble row application or repair is shown in FIGS. 6A-6C. The methodinvolves fixing a piece of soft tissue 130, e.g., rotator cuff, withrespect to bone 150. If the tissue augmentation blocks 110 a, 110 b aredried, the tissue augmentation blocks 110 a, 110 b can requirerehydrating ahead of the procedure. An incision can be made to performthe procedure using any one of a traditional open repair, anarthroscopic repair, or a mini-open repair. Once the surgeon has accessto the surgical site and the tissue and bone have been preparedaccording to accepted surgical techniques, the surgeon can use a medialrow stitch 140 to install the suture 112 in the soft tissue 130.Alternatively, any known stitch can be used. As shown in FIGS. 6A-6C,the medial row stitch 140 results in two suture limbs 112 a, 112 bextending outwardly from the soft tissue.

As shown in FIG. 6B, the tissue augmentation blocks 110 a, 110 b aredisposed on suture limbs 112 a, 112 b, respectively. The tissueaugmentation blocks 110 a, 110 b can be threaded onto the suture limbs112 a, 112 b by hand, with an installation tool 200′ (not shown), and/orwith a threader 206, 206′. As discussed above with reference to FIG. 3,if the installation tool 200′ is used, a suture limb 112 a can be passedthrough the opening, or cinch loop, 212, then the handle portion 208 canbe pulled to pull the threader 206 and suture limb through the tissueaugmentation block 110 a. Likewise, if just a threader 206, 206′ isused, a force can be applied to the threader to draw the suture limb 112a into and through the tissue augmentation block. Once the suture limb112 a has been threaded in the tissue augmentation block 110 a, thethreader 206 can be removed, and, if the installation tool 200′ wasused, the tissue augmentation block 110 a released from the installationtool 200′. The tissue augmentation blocks 110 a, 110 b can be threadedonto the suture limbs 112 a, 112 b at the surgical site inside of thebody. Alternatively, the tissue augmentation blocks 110 a, 110 b can bethreaded outside of the body.

Once the blocks 110 a, 110 b have been threaded onto the suture limbs112 a, 112 b, they can be advanced in the direction D₁ along therespective suture limbs 112 a, 112 b. In the illustrated embodiment, theblocks 110 a. 110 b are disposed proximate to the medial stitch 140because the length of the blocks 110 a, 110 b is similar to the lengthof the distance extending between the medial stitch 140 and the end ofthe tissue 130. However, in embodiments in which the length of theblocks 110 a, 110 b is less than that distance, the blocks 110 a, 110 bmay not necessarily be proximate to the medial stitch 140, but canextend along some portion of the length of the limbs 112 a, 112 bextending between the medial stitch 140 and the end of the tissue 130.After the blocks 110 a, 110 b have been installed on the respectivesuture limbs 112 a, 112 b, the free ends of the suture limb 112 a, 112 bcan be secured within the body. For example, the free ends of eachsuture limb 112 a, 112 b can be coupled to respective anchors 160 a, 160b, as shown in FIG. 6C, which in some exemplary embodiments can beknotless anchors. The suture limbs 112 a, 112 b can then be tightened tosecure the soft tissue 130 to the bone 150 before the anchors 160 a, 160b are fully fixed in the bone 150, thus completing the double rowlateral fixation associated with the medial stitch 140.

This procedure can be repeated as many times as required tosatisfactorily fixate the soft tissue 130 to the bone 150. The blocks110 a, 110 b provide a greater footprint for the limbs 112 a, 1112 b,and they may provide a greater surface area to distribute the loadingforces of the suture limbs 112 a, 112 b onto the soft tissue 130. Whilethe patient is healing from the procedure, new bands of tendon liketissue can form around the suture limbs 112 a, 112 b and into and aroundthe blocks 110 a, 110 b to result in a more robust tissue formation inthe soft tissue and between the soft tissue and bone. For example,blocks made from collagen scaffold or acellular dermal matrix materialcan be capable of remodeling while the patient is healing from theprocedure into tendon like tissue and integrate with the native tissue.The additional coverage of tendon like tissue across the soft tissue canincrease the strength of the tissue-to-bone connection and may preventfurther injury.

Another exemplary soft tissue repair method is provided for in FIGS.7A-7D. As shown, soft tissue 1030 is fixated to bone 1050 using analternative double row application. Once the surgeon has access to thesurgical site and the tissue, bone, and blocks 1010 a-1010 c have beenprepared according to accepted surgical techniques, including thoseprovided for herein, the surgeon can use medial row stitches 1040, 1042to install sutures 1012, 1016 respectively, in the tissue 1030. Theblocks 1010 a-1010 c can be similar to the blocks 110, 3010, 3110, orsimilar to other blocks and constructs as provided for in the presentdisclosure. Further, any known stitch can be used. The medial row stitch1040 results in two suture limbs 1012 a, 1012 b extending outwardly fromthe soft tissue, and the second medial row stitch 1042 results in twosuture limbs 1016 a, 1016 b extending outwardly from the soft tissue.

As shown in FIG. 7A, the blocks 1010 a-1010 c are threaded onto suturelimbs 1012 a, 1012 b, 1016 b, respectively, using techniques providedfor throughout the present disclosure. For example, as illustrated inFIG. 7A, the block 1010 a is threaded onto suture limb 1012 a with thethreader 206. Once the block 1010 a has been threaded onto the suturelimb 1012 a, as shown in FIG. 7B, it can be advanced in the directionD₁′ along the suture limb 1012 a until it is proximate the medial stitch1040 since the length of the block 1010 a is similar to the distanceextending between the medial stitch 1040 and the end of the tissue 1030.Similarly, blocks 1010 b, 1010 c can be advanced along the suture limbs1012 b, 1016 b until they are proximate the medial stitches 1040, 1042,respectively. The block 1010 a can be advanced along the suture limbswith an instrument like a knot pusher 1080 or other instrument suitablefor advancing the strip along the limb.

Once the blocks 1010 b, 1010 c have been installed on the respectivesuture limbs 1012 b, 1016 b, as shown in FIG. 7C, the free ends ofsuture limbs 1012 b, 1016 b can be secured within the body, for instanceby attaching them to the anchor 1060 b in a lateral row fixation.Similarly, once the block 1010 a has been installed on the suture limbs1012 a, the free ends of the suture limbs 1012 a, 1016 a can be securedwithin the body, for instance, by attaching them to anchor 1060 a in alateral row fixation. As shown in FIG. 7C, the suture limbs 1012 b, 1016b are installed into the anchor 1060 b before the suture limbs 1012 a,1016 a are installed into the anchor 1060 a, such that suture limb 1016a rests atop the block 1010 b. Alternatively, suture limb 1016 a can beplaced under suture limb 1012 b by changing the order of fixation. Thesuture limbs 1012 a, 1012 b, 1016 a, 1016 b, can be tightened to securethe soft tissue 1030 to the bone 1050 before the anchors 1060 a, 1060 bare fully fixed in the bone 1050, as shown in FIG. 7D.

An alternative exemplary method of soft tissue repair is illustrated inFIGS. 8A and 8B. The method fixates soft tissue 1030′ to bone 1050′ withan alternative double row application using the washers 310, as shownwashers 310 a, 310 b, and 310 c, in place of blocks 10, 110. Thealternative double row application disclosed with respect to FIGS. 8Aand 8B helps reduce added bulk that can occur when two constructs arestacked on top of each other when suture limbs cross each other as partof the repair design. Further, the use of washers in such formationshelps reduce the possibility of any bunching that may occur when usingconstructs that are of a block configuration. Once the surgeon hasaccess to the surgical site and the tissue, bone, and washers 310 a-310c have been prepared according to accepted surgical techniques,including those provided for herein, the surgeon can use an initialmattress stitch to install sutures 1012′, 1016′ in the tissue 1030′.Alternatively, any known stitch can be used. A medial row stitch 1040′in the tissue 1030′ results in two suture limbs 1012 a′, 1012 b′extending outwardly from the tissue, and second medial row stitch 1042′results in two suture limbs 1016 a′, 1016 b′ extending outwardly fromthe tissue.

While the following discussion is made only to suture limb 1012 a′, forthe sake of clarity, suture limbs 1012 b′, 1016 a′, 1016 b′, can havewashers 310 threaded thereon in substantially the same manner. Washers310 a-310 c are threaded onto suture limb 1012 a′, as illustrated inFIG. 8A. Alternatively, any number of washers 310 can be used on any ofthe suture limbs 1012 a′, 1012 b′, 1016 a′, 1016 b′. The washers 310a-310 c can be threaded onto the suture limb 1012 a′ by hand, with aninstallation tool, and/or with a threader using techniques provided forthroughout the present application. Once washers 310 a-310 c have beenthreaded onto the suture limb 1012 a′ they can be advanced along thesuture limb 1012 a′. In the illustrated embodiment washers 310 a-310 care disposed such that they are equally spread out over the tissue 1030′along the length of limb 1012 a′. After the washers 310 have beeninstalled on the respective suture limbs 1012 a′, 1012 b′, 1016 a′, 1016b′, as shown in FIG. 8A, the free ends of the suture limbs 1012 a′, 1016a′ and 1012 b′, 1016 b′ can be secured within the body, for instance, byattaching them to anchors 1060 a′ and 1060 b′, respectively. In theillustrated embodiment the suture limbs 1012 b′, 1016 b′ are coupled tothe anchor 1060 b′ before the suture limbs 1012 a′, 1016 a′ are coupledinto anchor 1060 a′, thus causing the suture limb 1016 a′ to rest atopthe suture limb 1012 b′, although other configurations are possiblewithout departing from the spirit of the present disclosure. The suturelimbs 1012 a′, 1012 b′, 1016 a′, 1016 b′ can be tightened to secure thesoft tissue 1030′ to the bone 1050′ before the anchors 1060 a′, 1060 b′are fully fixed in the bone 1050′.

A further exemplary double row fixation method is illustrated in FIG.8B. The method for fixing soft tissue 1030″ to bone 1050″ issubstantially the same as the method illustrated in FIG. 8A but itfurther includes the use of the circular washers 410, as shown washers410 a and 410 b, at a location of the medial stitch (not visible). Theplacement of the washers 410 a, 410 b as shown provides protection ofthe stitches disposed beneath the washers 410 a, 410 b, while alsoincreasing the footprint of the suture limbs 1012 a″, 1012 b″, 1016 a″,1016 b″ and allowing for the distribution of forces across a surface ofthe washers 410 a, 410 b that would otherwise be applied directly to thetissue 1030″. In use, the washers 410 a, 410 b can be threaded onto therespective suture limbs 1012 a″, 1012 b″, 1016 a″, 1016 b″ before thewashers 310′ are threaded onto the suture limbs 1012 a″, 1012 b″, 1016a″, 1016 b″. The double row fixation method can then be completed, forexample, according to the process described above with regards to FIG.8A. With respect to both the configurations illustrated in FIGS. 8A and8B, the greater an angle formed by the sutures extending from theanchors 1060 a′, 1060 b′ and the washers 410 a, 410 b, the greater thestability of the repair.

A still further alternative method for securing soft tissue 1030′″ tobone 1050′″ using a double row fixation technique is illustrated in FIG.9. Once the surgeon has accessed the surgical site and the tissue, bone,and blocks 1010 a′″-d′″ have been prepared according to the acceptedsurgical techniques, including those provided for herein, the surgeoncan use initial mattress stitches 1040′″, 1042′″ to install sutures 1012a′″-c′″ and 1016 a′″-c′″, respectively, in the tissue 1030′″. A firstmedial row anchor 1060 a′″ can be inserted into the bone 1050′″ havingthree suture limbs 1012 a′″-c′″ extending therefrom, the three suturelimbs 1012 a′″-c′″ being threaded through the tissue 1030′″ with a firstmedial row stitch 1040′″. A second medial row anchor 1060 b′″ can beinserted into the bone 1050′″ having three suture limbs 1016 a′″-c′″extending therefrom, the three suture limbs 1016 a′″-c′″ being threadedthrough the tissue 1030′″ with a second medial row stitch 1042′″.

As illustrated, block 1010 a′″, which can be in the form of a strip,tube, or cannulated block, among other disclosed configurations, isthreaded onto one of the suture limbs 1012 a′″, 1016 a′″ usingtechniques provided for throughout this disclosure, and suture limbs1012 a′″ and 1016 a′″ are tied together with a knot to secure the tissue1030′″ to the bone 1050′″. Furthermore, once the knot has been formed,the block 1010 a′″ can be moved to cover the knot to reduce thepossibility of tissue being damaged by the knot. Blocks 1010 b′″, 1010c′″ can then threaded onto suture limbs 1012 b′″, 1012 c′″,respectively, using techniques provided for throughout this disclosure,and advanced to a location proximate the medial stitch 1040′″.Similarly, once blocks 1010 d′″, 1010 e′″ have been threaded onto thesuture limbs 1016 b′″, 1016 c′″, they can be advanced to a locationproximate the medial stitch 1042′″. After the blocks 1010 b′″, 1010 d′″and 1010 c′″, 1010 e′″ have been installed on the respective suturelimbs 1012 b′″, 1016 b′″ and 1012 c′″, 1016 c′″, the free ends of thesuture limbs 1012 b′″, 1016 b′″ and 1012 c′″, 1016 c′″ can be securedwithin the body. For example, the free ends of each suture limb 1012b′″, 1016 c′″ and 1012 c′″, 1016 b′″ can be coupled to the respectiveanchor 1062 a′″ and 1062 b′″. The suture limbs 1012 b′″, 1012 c′″, 1016b′″, 1016 c′″, can be tightened to secure the soft tissue 1030′″ to thebone 1050′″ before the anchors 1062 a′″, 1062 b′″ are fully fixed in thebone 1050′″.

A further alternative double row fixation method of soft tissue repairis illustrated in FIGS. 10A-10E using the tissue augmentation construct2810 a of FIG. 2G, along with an identically configured tissueaugmentation construct 2810 b (as shown in FIG. 10E). The two constructsdo not need to be identically configured, as they could be similarlyconfigured and/or can have other configurations provided for herein orotherwise known to those skilled in the art. The method can fixate softtissue 2830 to bone 2850 with an alternative extra-long blockapplication to provide for additional coverage of the repair.

Once the surgeon has access to the surgical site and the tissue, bone,and tissue augmentation blocks have been prepared according to acceptedsurgical techniques including those provided for herein, the surgeon caninsert a first anchor 2860 a below the soft tissue 2830. The firstanchor 2860 a can have two suture limbs 2812 a, 2812 b extendingtherefrom. The two suture limbs 2812 a, 2812 b can be passed through thesoft tissue 2830 to begin to assist in fixating the soft tissue 2830 tothe bone 2850. A first mattress stitch 2840 a can be made in the softtissue 2030 medial to the first anchor 2860 a. The first mattress stitch2840 a can result in two suture limbs 2814 a, 2814 b extending out ofthe soft tissue 2830.

The block 2810 a can be threaded onto suture limbs 2812 a, 2814 a usingtechniques provided for throughout the present disclosure. For example,the suture limb 2814 a can be associated with the proximal end 2811 p ofthe first block 2810 a by advancing the first threader 2809 a in a firstdirection D1, as shown in FIG. 10B (the threader 2809 a is notillustrated, but in view of the present disclosures, a person skilled inthe art will understand how the threader 2809 a can be operated to passthe suture limb 2814 a through the proximal end 2811 p of the firstblock 2810 a). Further, the suture limb 2812 a can be associated with anintermediate 2811 i and distal portion 2811 d of the block 2810 a asshown by advancing the second threader 2809 b in a second direction D2,as also shown in FIG. 10B. Although the respective threaders 2809 a,2809 b for the respective suture limbs 2814 a, 2812 a are notillustrated, a person skilled in the art, in view of the presentdisclosures, will understand how the threaders can be operated to passthe respective suture limbs through portions of the first block 2810 a.The block 2810 a can then be advanced medially such that the proximalend 2811 p of the block 2810 a is proximate the first mattress stitch2840 a, as shown in FIG. 10C. This process can be repeated for thesecond block 2810 b and its respective limbs 2816 a, 2818 b. Forexample, a second anchor 2862 a can be installed below the soft tissue2830, as shown in FIG. 10E, with the anchor 2862 b having two repairsuture limbs 2816 a, 2816 b extending from it. The two repair limbs 2816a, 2816 b can be similarly passed through the soft tissue 2830 and asecond mattress stitch 2840 b (illustrated in FIG. 10E) can be made inthe soft tissue 2030, medial to the second anchor 2862 a. The secondmattress stitch 2840 b can result in two suture limbs 2818 a, 2818 bextending out of the soft tissue 2830. The resulting suture limbs 2816a, 2816 b, 2818 a, 2818 b can be associated with block 2810 b tocontinue the tissue fixation repair.

After the blocks 2810 a, 2810 b have been installed on the respectivesuture limbs 2812 a, 2814 a and 2816 a, 2818 a, the free ends of thesuture limbs 2812 a, 2812 b, 2816 a, 2816 b can be secured within thebody. For example, the free ends of each suture limb 2812 a, 2816 b and2812 b, 2816 a can be coupled to the respective anchor 2860 b and 2862b, as shown in FIGS. 10C and 10E. In the illustrated embodiment, suturelimb 2812 b and suture limb 2816 b can be passed over the soft tissue2830 to form an “X” configuration or shape such that suture limb 2812 bis secured in the same anchor 2862 b as suture limb 2816 a and suturelimb 2816 b is secured in the same anchor 2860 b as suture limb 2812 a.Suture limbs 2812 a, 2816 a can be disposed through the respectivecentral lumens 2870 a, 2870 b of the blocks 2810 a, 2810 b to increasethe footprint of the suture limbs 2812 a, 2816 a, subsequentlydecreasing the likelihood of damaging the soft tissue 2830 as discussedabove. Because the blocks 2810 a, 2810 b have a sufficient length, theycan be installed so that they extend medially over first and secondrepairs 2838 a, 2838 b, as shown in FIG. 10E. The suture limbs 2812 a,2812 b, 2816 a, 2816 b can then be tightened to secure the soft tissue2830 to the bone 2850 before the anchors 2860 b, 2862 b are fully fixedin the bone 2850. The two limbs 2814 a, 2814 b can be tied together witha knot 2880 a, and limbs 2818 a, 2818 b can be tied together with a knot2880 b to secure the proximal ends 2811 p of the respective blocks 2810a, 2810 b at a location medial of the repairs 2838 a, 2838 b, as shownin FIGS. 10D and 10E. A person skilled in the art will recognize anumber of repairs that can be represented by the repairs 2838 a, 2838 bin view of the present disclosure and the skilled person's knowledge.

Rotator Cuff Repairs—Single Row Applications

Another method of soft tissue repair is illustrated in FIGS. 11A-11C.The method fixates soft tissue 130′ to bone 150′ using a single rowapplication. Once the surgeon has access to the surgical site and thetissue, bone, and blocks 110 a′, 110 b′ have been prepared according toaccepted surgical techniques, including those provided for herein, thesurgeon can use an initial mattress stitch to install suture 112′ in thesoft tissue 130′. Alternatively, any known stitch can be used. Themattress stitch 140′ results in two suture limbs 112 a′, 112 b′extending outwardly from the soft tissue.

As shown in FIG. 11B, the blocks 110 a′, 110 b′ are threaded on tosuture limbs 112 a′, 112 b′, respectively, using techniques provided forthroughout the present application. Once the blocks 110 a′, 110 b′ havebeen threaded onto the suture limbs 112 a′, 112 b′, they are advanced inthe direction D₁′ along the respective sutures until they are proximatethe mattress stitch 140′. As described above, the location of the stripswith respect to the stitch 140′ can depend, at least in part, on thesize of the blocks 110 a′, 110 b′ and the distance between the stitch140′ and the end of the tissue 130′. After the blocks 110 a′, 110 b′have been installed on the respective suture limbs 112 a′, 112 b′, thefree ends of the suture limbs 112 a′, 112 b′ can be secured within thebody, for instance, by attaching them to a single anchor 160′, as shownin FIG. 11C. The suture limbs 112 a′, 112 b′ can be tightened to securethe soft tissue 130′ to the bone 150′ before the anchor 160′ is fullyfixed in the bone 150′, thus completing the single row fixationassociated with the medial stitch 140′. In some exemplary embodiments asecond anchor having two suture limbs extending therefrom, each limbhaving at least one tissue augmentation construct disposed thereon, canbe implanted in a similar manner as the anchor 160′, limbs 112 a′, 112b′, and blocks 110 a′, 110 b′ with respect to the same tissue 130′ andbone 150′ to provide a second securement system for the tissue. As withall of the various configurations provided for herein, any number andcombination of implants, e.g., bone anchors, sutures, and tissueaugmentation constructs can be used to secure soft tissue to bone.

Alternative single row applications are shown in FIGS. 11D-11F. In afirst alternative single row application illustrated in FIG. 11D, astandard single row repair can be completed using two anchors 160 a″,160 b″ installed in the bone 150″ below the tissue 130″. Anchors 160 a″,160 b″ can each have two suture limbs 112 a″, 112 b″ and 116 a″, 116 b″extending therefrom, respectively. Suture limbs 112 a″ and 116 a″ can bethreaded through the soft tissue 130″ and used to bring the soft tissue130″ into contact with the bone 150″. Sutures limbs 112 b″ and 116 b″can similarly be threaded through the soft tissue 130″.

As shown in FIG. 11D, a tissue augmentation block 110″ can be threadedon to one of the suture limbs 112 b″, 116 b″ using techniques providedfor throughout this disclosure and advanced to a desired location withrespect to the tissue 130″. After the augmentation block 110″ has beeninstalled on one of the suture limbs, the free end of each suture limb112 b″, 116 b″ can then be tied together using a knot, not shown.Furthermore, the block 110″ can be moved into position such that itcovers the knot, thereby minimizing any potential tissue abrasion by theknot, and is in contact with the tissue 130″.

A second alternative single row application is illustrated in FIG. 11E.Similar to the procedure of FIG. 11D, a standard single row repair canbe completed using two anchors 160 a′″, 160 b′″ installed in bone 150′″below tissue 130′″. As shown, a first suture 111′″ can be installedmedially of the repair with a mattress stitch 140 a′″, such that twosuture limbs 111 a′″, 111 b′″ extend from the tissue 130′″, and a secondsuture 113′″ can be installed medially of the repair with a secondmattress stitch 140 b′″, such that two suture limbs 113 a′″, 113 b′″extend from the tissue 130′″. In some instances, after the two mattressstitches 140 a′″, 140 b′″ have been installed in the tissue 130′″,anchors 160 a′″, 160 b′″ can be installed into the bone 150′″ below thetissue 130′″. Operative sutures 112′″, 114′″ can be used to couple thetissue 130′″ to the anchors 160 a′″, 160 b′″ respectively attachedthereto according to accepted surgical practice.

Tissue augmentation blocks 110 a′″-d′″ can be threaded on to the suturelimbs 111 a′″, 111 b′″, 113 a′″, 113 b′″ using techniques provided forthroughout this disclosure and can be advanced along the respectivesutures to desired locations. The free ends of the suture limbs 111 a′″,113 a′″ and 111 b′″, 113 b′″ can be tied to, and tightened about,operative sutures 112′″, 114′″ respectively.

FIG. 11F illustrates a further alternative single row application. Afirst suture 111″″ can be installed medially with a mattress stitch 140a″″ such that two suture limbs 111 a″″, 111 b″″ extend from the tissue130″″, and a second suture 113″″ can be installed with a second mattressstitch 140 b″″ such that two suture limbs 113 a″″, 113 b″″ extend fromthe tissue 130″″. After the first and second sutures 111″″, 113″″ havebeen installed, first and second medial anchors 160 a″″, 160 b″″ areinstalled in the bone 150″″, below the tissue 130″″. Operative sutures112″″, 114″″ coupled to anchors 160 a″″, 160 b″″, respectively, can beused to perform the repair such that the tissue 130″″ is brought intocontact with the bone 150″″, according to accepted surgical practices.Once the tissue 130″″ has been repaired, blocks 110 a″″-d″″ can beinstalled onto suture limbs 111 a″″, 111 b″″, 113 a″″, 113 b″″ usingtechniques provided for throughout this disclosure. Free ends of thesuture limbs 111 a″″, 113 a″″ and 111 b″″, 113 b″″ can be secured withinthe body, for instance, by attaching them to anchors 160 c″″ and 160d″″, respectively. The suture limbs 111 a″″, 111 b″″, 113 a″″, 113 b″″can be tightened to further secure the blocks 110 a″″-d″″ to the softtissue 130″″ such that the repairs made with the sutures 112″″, 114″″are covered by tissue augmentation blocks.

A further exemplary method of soft tissue repair is illustrated in FIG.12. The method fixates a piece of soft tissue 1130, e.g., rotator cuff,to bone 1150 using a single row fixation. Once the surgeon has access tothe surgical site and the tissue, bone, and tissue augmentation blockhave been prepared according to accepted surgical techniques includingthose provided for herein, the surgeon can use a mattress row stitch1140 to install sutures 1112, 1114 and mattress row stitch 1142 toinstall sutures 1116, 1118 in the soft tissue 1130. Sutures 1112, 1114and 1116, 1118 are installed into anchors 1160 a, 1160 b, respectively,below the tissue 1130 in the bone 1150. As shown in FIG. 12, each of themattress stitches 1140 and 1142 results in four suture limbs 1112 a,1112 b, 1114 a, 1114 b and suture limbs 1116 a, 1116 b, 1118 a, 1118 bextending outwardly from the soft tissue.

At least one block 310′ can be threaded on at least one of the suturelimbs of each suture 1112, 1114, 1116, 1118. Block 310′ can be similarto block 310, although one difference between the two is that athickness of the block 310′ is greater than the thickness of block 310.Alternatively, block 310′ can have any suitable dimension as desired fora given procedure. In some embodiments, each of the suture limbs 1112 a,1114 a, 1116 a, 1118 a can have a block 310′ threaded thereon usingtechniques provided for throughout the present disclosure, and then thetwo suture limbs of each pair can be tied together. For example, suturelimbs 1112 a, 1112 b can be tied together after block 310′ has beenthreaded thereon. After the suture limbs 1112 a, 1112 b have been tiedtogether, the block 310′ can be moved over the knot to buffer, or cover,the knot. This process can be repeated for each of the suture limb pairs1114 a and 1114 b, 1116 a and 1116 b, and 1118 a and 1118 b.

A still further exemplary method of soft tissue repair is illustrated inFIG. 13. The method fixates a piece of soft tissue 1230, e.g., rotatorcuff, to bone 1250 using a single row rip-stop stitch. Once the surgeonhas access to the surgical site and the tissue, bone, and tissueaugmentation constructs have been prepared according to acceptedsurgical techniques including those provided for herein, the surgeon canuse a stitch 1240 to couple the sutures 1212, 1214 to anchor 1260 a anda stitch 1242 to couple the sutures 1216, 1218 to anchor 1260 b. Anyknown stitch can be used. As shown in FIG. 13, the stitch 1240 resultsin four suture limbs 1212 a, 1212 b, 1214 a, 1214 b extending outwardlyfrom the soft tissue, and the stitch 1242 also results in four suturelimbs 1216 a, 1216 b, 1218 a, 1218 b extending outwardly from the softtissue.

A tissue augmentation block 1210 can be threaded on to one of the suturelimbs associated with each mattress knot 1240, 1242 using techniquesprovided for throughout the present disclosure. The block 1210 in theillustrated embodiment is a construct similar to the bars 3010, 3110. Inthe illustrated embodiment, the suture limbs 1212 a and 1216 a each havethe block 1210 associated with it. Once each of the suture limbs 1212 a,1216 a has a block 1210 threaded thereon, the suture limbs 1212 a, 1216a can be tied together with a complementary suture limb 1212 b, 1216 b,respectively. Furthermore, the block 1210 can be slid over the knot tobuffer, or cover, the knot, as illustrated. Then the suture limbs 1214a, 1214 b can be tied together over the top of block 1210 to create arip-stop stitch. Advantageously, suture limbs 1214 a, 1214 b, once tiedtogether will be prevented from tearing through the soft tissue 1230because the block 1210 will act as a buffer thereby distributing theapplied load. This process can be repeated for the second mattressstitch 1242.

FIG. 14 illustrates a further method of soft tissue repair. The methodprovides for fixating a piece of soft tissue 1330, e.g. rotator cuff, tobone 1350, using an anterior-posterior mattress stitch extending betweenanchors. Once the surgeon has access to the surgical site and thetissue, bone, and tissue augmentation block have been prepared accordingto accepted surgical techniques including those provided for herein, thesurgeon can thread two limbs 1312 a, 1312 b of a suture 1312 coupled toan anchor 1360 a through tissue 1330. Similarly, a second anchor 1360 bcan be implanted in the bone 1350 having suture limbs 1314 a, 1314 b ofa suture 1314 extending from the anchor 1360 b through tissue 1330. Anyknown stitch can be used.

One block 1310 can be threaded on to either of the suture limbs 1312 a,1314 a of either anchor 1360 a, 1360 b using techniques provided forthroughout the present disclosure. The illustrated block 1310 has alength approximately in the range of about 10 millimeters to about 20millimeters, a width approximately in the range of about 2 millimetersto about 5 millimeters, and a height approximately in the range of about1 millimeter to about 3 millimeters. Once the suture limb 1312 a has ablock 1310 threaded thereon, the suture limb 1312 a can be tied togetherwith the suture limb 1314 a. Furthermore, after the suture limbs 1312 a,1314 a have been tied together, the block 1310 can be slid over theknot, not shown, to buffer, or cover, the knot. Then the suture limbs1312 b, 1314 b can be tied together over the block 1310. Advantageously,the suture limbs 1312 b, 1314 b, once tied together, will be preventedfrom tearing through the soft tissue 1330 because the block 1310 willact as a buffer between them distributing the applied load.

An alternative single row fixation method of soft tissue repair isillustrated in FIG. 14. The method fixates soft tissue 1430 to bone 1450with an alternative, extra-long and extra-wide block application. Oncethe surgeon has access to the surgical site and the tissue, bone, andtissue augmentation blocks have been prepared according to acceptedsurgical techniques including those provided for herein, the surgeon canfixate the soft tissue 1430 to the bone 1450 according to acceptedsurgical techniques to create the repairs 1438 a, 1438 b, shown inphantom. Once the repairs 1438 a, 1438 b are completed, a first mattressstitch 1440 is made through the soft tissue 1430, medial to the softtissue repair 1438 a, and a second mattress stitch 1442 is made, medialto the repair 1438 b, to install the sutures 1412 and 1414 in the softtissue 1430. The first mattress stitch 1440 results in two suture limbs1412 a, 1412 b extending outwardly from the soft tissue 1430, and thesecond mattress stitch 1442 results in two suture limbs 1414 a, 1414 bextending outwardly from the soft tissue. Alternatively, the stitches1440, 1442 can be made before the repairs 1438 a, 1438 b are performed.

The blocks 1410 a-1410 c have a configuration that can be considered tobe a larger version of some other block configurations provided forherein. As shown, the blocks 1410 a-1410 c have a substantiallyrectangular shape, like the cannulated block configurations 3010, 3110of FIGS. 2E and 2F, but with a more substantial thickness. Otherconfigurations of the blocks 1410 a-1410 c, particularly in view of thepresent disclosures, are also possible, including but not limited toconfigurations that are more akin to one or more of the tape strips 10,the tubes 110, and the washers 310, 410, or combinations thereof. In oneexemplary embodiment, the blocks 1410 a-1410 c can have a lengthapproximately in the range of about 15 millimeters to about 25millimeters, a width approximately in the range of about 4 millimetersto about 5 millimeters, and a thickness approximately in the range ofabout 1 millimeter to about 3 millimeters.

The blocks 1410 a, 1410 c can be threaded onto suture limbs 1412 a, 1414a using techniques provided for throughout the present disclosure. Inthe illustrated embodiment, the block 1410 b has two suture limbs, thesuture limbs 1412 b and 1414 b, associated with it. While this latterconfiguration can also be achieved using the techniques provided forthroughout the present disclosure, in one exemplary method, a singleinstallation tool can be used to associate both suture limbs 1412 b,1414 b with the block 1410 b at the same time. For example, the threader206 (not shown) can be disposed in the block 1410 b and can have bothlimbs passed through its distal opening 212 (not shown) before operatingthe threader as described above to associate the limbs 1412 b, 1414 bwith the block 1410 b. Alternatively, the block 1410 b can have twothreaders disposed therethrough to thread the suture limbs 1412 b, 1414b individually therethrough. In a further alternative, a single threadercan be threaded through the block 1410 b to pull the suture limb 1412 bthrough the block 1410 b, and then the threader, or a differentthreader, can be inserted into the block 1410 b to thread the suturelimb 1414 b through the block 1410 b.

Once the blocks 1410 a-1410 c have been threaded onto the suture limbs1412 a, 1412 b, 1414 a, 1414 b they can be advanced along the suturelimbs 1412 a, 1412 b, 1414 a, 1414 b, respectively, until they areproximate the medial stitches 1040, 1042. One advantage of the blocks1410 a-1410 c is that they can be sized to cover a substantial portionof a surgical site that includes a perimeter defined by the anchors 1460a, 1460 b and the mattress stitches 1440, 1442. Other advantages oftissue augmentation constructs provided for herein are also applicable.After the blocks 1410 a-1410 c have been installed on the respectivesuture limbs, the free ends of the suture limbs 1412 a, 1412 b and 1414a, 1414 b can secured within the body, for instance, by attaching themto anchors 1460 a and 1460 b, respectively. The suture limbs 1412 a,1412 b, 1414 a, 1414 b, can be tightened to secure the soft tissue 1430to the bone 1450 before the anchors 1460 a, 1460 b are fully fixed inthe bone 1450.

The various embodiments described above can be used in conjunction withany of the other embodiments described above such that some of the softtissue is secured with a double-row application and some portions aresecured with the single row application. Still further, any number ofsuture limbs and tissue augmentation blocks can be used during anyparticular procedure, including disposing multiple strips on a singlelimb and/or using only a single limb or more than two limbs.

Rotator Cuff Repairs—Partial Tear Repairs

An exemplary method of partial tear soft tissue repair is illustrated inFIGS. 16A-16C. The method fixates a piece of soft tissue 1530, e.g.rotator cuff, to bone 1550 in a situation where a partial tear occurs.As shown in FIG. 16A, soft tissue 1530 is maintained in contact with thebone 1550 at 1530 d. The length X shows what a “healthy” footprint ofcontact should be between the tissue 1530 and bone 1550. This procedurecan aid in the reattachment of the soft tissue to the bone to create a“healthy” footprint. Prior art procedures can result in a depression atthe attachment point due to the necessary compression of the sutureagainst the tissue, thus causing a weakening of the tissue, and moregenerally, the rotator cuff.

Once the surgeon has access to the surgical site and the tissue, bone,and the tissue augmentation construct have been prepared according toaccepted surgical techniques, including those provided for herein, thesurgeon can install an anchor 1560 into the bone 1550. The anchor 1560can have a suture 1512 coupled thereto having two suture tails 1512 a,1512 b extending therefrom that can be passed through the soft tissue1530. A block 1510 can be threaded onto at least one of the suture tails1512 a, 1512 b. The block 1510 can be any of the configurations providedfor herein, including but not limited to the blocks 10, 110, 3010, 3110,310, and 410 and the patches 2210, 2310, 2410, and 2510, which aredescribed below. The constructs 1510 can be threaded onto the suturelimb 1512 a, for example, using techniques provided for throughout thepresent disclosure, and advanced along the suture 1512 a until it isproximate the tissue 1530. After the construct 1510 has been installedon one of the suture limbs, the free end of each suture limb 1512 a,1512 b can then be tied together using a knot, not shown, to bring thedamaged tissue 1530 into contact with the bone 1550. The construct 1510can then be moved into position such that it covers the knot and is incontact with the tissue 1530. As shown in FIG. 16B, the construct 1510,once installed, can add height to the depression to build back height tothe repaired tissue 1530.

Methods of Use—Non-Rotator Cuff Repairs

The present disclosure contemplates that the tissue augmentationconstructs provided for herein have applications outside of rotator cuffrepairs as augmentation constructs. Some, non-limiting examples of thosealternative procedures are provided for below. These examples are by nomeans exhaustive. Further, a person having skill in the art willunderstand how some of the disclosures provided for in this non-rotatorcuff repair section can be adapted for use in rotator cuff repairprocedures. Each of the embodiments described below, including thosediscussed after the non-rotator cuff repairs (i.e., labrum repair oraugmentation, ACL repair, Achilles repair, AC joint-repair, meniscalrepair, and superior capsule reconstruction), are discussed with respectto using a tissue augmentation construct, which includes any of theblocks and patches disclosed herein or otherwise derivable from thepresent disclosure. A person skilled in the art, in view of the presentdisclosures, will understand how to adapt various tissue augmentationconstructs for use in the various procedures. Further, in exemplaryembodiments of each of the methods described in the present disclosure,collagen, for example, can be used as part of, or to form entirely oralmost entirely, the construct. This allows the construct to grow in thearea of the repair once healed. Other materials can also be used to formthe constructs, including others that achieve a similar result ascollagen.

Non-Rotator Cuff Repairs—Labrum Defect Corrections

One alternative procedure is illustrated in FIGS. 17A-17D. The methoduses a tissue augmentation construct 1610, or constructs, to fill in agap where soft tissue 1630 has been damaged and torn from the bone 1650.For example, as shown in FIG. 17A, a labrum 1630 can have a tear ordefect 1635 where a portion of the bone 1650 is exposed. Once thesurgeon has access to the surgical site and the tissue, bone, and tissueaugmentation construct have been prepared according to accepted surgicaltechniques including those provided for herein, the surgeon can installa first anchor 1660 a into the bone at a proximal location 1635 p of thetear 1635. The first anchor 1660 a has a suture 1612 installed therein.The tissue augmentation construct 1610 can be threaded onto the suturelimb 1612 using techniques provided for throughout the presentdisclosure, and advanced along the suture until the tissue augmentationconstruct 1610 is proximate the proximal end of the tear 1635 p. Anytype of tool provided for herein or otherwise known to those skilled inthe art can be used to advance the construct 1610 towards the anchor1660 a, including a knot pushing tool. The tissue augmentation construct1610 can be approximately the same length as defect 1635 once implanted,and can be pre-cut and/or cut at the surgical site in real time toassure proper fit.

After the tissue augmentation construct 1610 has been installed on thesuture limb 1612, the free end of the suture limb 1612 can then beanchored down to the bone with a second anchor 1660 b, such as aknotless-type fixation anchor. The tail of suture 1612 can be tightenedbefore the anchor 1660 b has been fully inserted into the bone. Bylocating the anchors 1660 a, 1660 b and construct 1610 in theselocations, the construct 1610 ends up on a back edge of the glenoidrather than on its face and the repair can be used to rebuild the labrumrather than just fix the defect, as was more typical in previous labrumrepair procedures. In an alternative embodiment, separate suturesextending from each of the two anchors 1660 a, 1660 b can be threadthrough the labrum on either side, the tissue augmentation construct1610 can be disposed on one of the two sutures, the two sutures can becoupled together, e.g., using a knot. Furthermore, the tissueaugmentation construct 1610 can be disposed over a location at which thetwo sutures are tied together to protect the location at which thesutures are coupled together.

Non-Rotator Cuff Repairs—ACL Repairs

Another alternative procedure is illustrated in FIGS. 18A-18C. Themethod uses a tissue augmentation construct 1710, or constructs, torepair a torn ACL. For example, as shown in FIG. 18A, one bundle of theACL 1702 is torn, or otherwise damaged. Once the surgeon has access tothe surgical site and the tissue, bone, and tissue augmentationconstruct have been prepared according to accepted surgical techniques,the surgeon can begin the partial ACL repair. First, a bone tunnel 1704is drilled through the femur 1706 and tibia 1707 next to the native,undamaged ACL 1708. Next, a tissue augmentation construct 1710, which asshown in FIG. 18B has suture limbs 1712 a, 1712 b extending from opposedends, is prepared in the same manner as described above with regards toother embodiments. The construct 1710 can have a length approximately inthe range of about 5 millimeters to about 100 millimeters. As shown inFIG. 18C, the construct 1710 can be threaded into the bone tunnel 1704such that construct 1710 is in contact with the undamaged ACL 1708. Thesuture limbs 1712 a, 1712 b can be used to fix the construct 1710 withinthe bone tunnel according to known surgical techniques.

Alternatively, the construct 1710 can be used to augment an autograftimplant. In situations where an autograft, or allograft, implant is tooshort, and/or too thin and not strong enough, to complete the repair,the construct 1710 can be sutured or otherwise coupled to the autograftimplant to create an implant of the required size. In a furtheralternative, a construct having a lumen extending therethrough can bethreaded over an autograft, or allograft, implant to further strengthenan autograft or allograft implant for an ACL repair.

Non-Rotator Cuff Repairs—Superior Capsule Reconstructions

Still another alternative procedure is illustrated in FIG. 19. Themethod can use at least one of tissue augmentation constructs 1810 a,1810 b to assist in anchoring down a superior capsule reconstructiongraft 1820 over a humeral head 1802. Once the surgeon has access to thesurgical site and the tissue, bone, tissue augmentation constructs, andsuperior capsule reconstruction graft have been prepared according toaccepted surgical techniques, including those provided for herein, thesurgeon can affix one end of the graft 1820 to the glenoid rim 1804. Thesurgeon can affix one end of the graft 1820 to the glenoid rim 1804 byinstalling a first medial anchor 1860 a having a suture 1812 a extendingtherefrom. A first tissue augmentation construct 1810 a can be threadonto the suture 1812 a using techniques provided for throughout thepresent disclosure, and the construct 1810 a can be tightened againstthe graft 1820 using techniques provided for herein or otherwise knownto those skilled in the art, such as for example, by tying suture 1812 ato suture 1812 b, not shown, both of which extend from the anchor 1860a. The pressure of the construct 1810 a on the graft 1820 can hold thegraft 1820 at a desired location with respect to the glenoid rim 1804.An opposite end of the graft 1820 can be anchored proximate to thehumeral head 1802 and a location and/or size of the graft 1820 adjustedso that the glenoid rim 1804 is brought into contact with the humeralhead 1802 in accordance with techniques used in superior capsulereconstruction procedures.

While a number of different techniques can be used to couple the otherend of the graft 1820 proximate to the humeral head 1802, in theillustrated embodiment first and second lateral anchors 1862 a, 1862 bare used in conjunction with a second tissue augmentation construct 1810b to make the repair. More particularly, in one exemplary embodiment, atleast one of the anchors 1862 a, 1862 b can have a suture 1812 bassociated therewith and the second tissue augmentation construct 1810 bcan be disposed on at least a portion of the suture 1812 b usingtechniques provided for in the present disclosure. The suture 1812 b canextend between the two anchors 1862 a, 1862 b, against using any of thetechniques provided for herein or otherwise known to those skilled inthe art, and the construct 1810 b can be tightened down against thegraft 1820 to help maintain a location of the graft 1820 with respect tothe humeral head 1802 while allowing the construct 1810 b to betterdistribute any force applied by the suture 1812 b across the surfacearea of the construct 1810 b. Any number of tissue augmentationconstructs can be used in the repair, and in alternative embodimentstissue augmentation constructs may only be used in conjunction withcoupling the graft 1820 with only one of the glenoid rim 1804 and thehumeral head 1802.

Repairing Soft Tissue by Closing Gaps—Rotator Cuff and Non-Rotator CuffExamples

Two exemplary embodiments for closing gaps or voids in tissue areillustrated in FIGS. 20A-F. The first illustrated embodiment, as shownin FIGS. 20A-20C, relates to a rotator cuff margin convergence, and thesecond, as shown in FIGS. 20D-20F, a hip capsular closure. However, aperson skilled in the art will recognize other types of procedures theseembodiments can be applied to in practice without departing from thespirit of the present disclosure.

FIG. 20A shows rotator cuff tissue 1930 having a void or gap 1905. Firstand second sutures 1912 a, 1912 b can be associated with first andsecond constructs 1910 a, 1910 b using techniques provided forthroughout the present disclosure. As shown in FIG. 20B, a first freeend of the first suture 1912 b can be threaded into the rotator cufftissue 1930 on a first side of the void 1905 and threaded back throughthe rotator cuff tissue 1930 on the opposite side of the void 1905. Thefirst free end can be tied to the second free end to bring edges 1930 a,1930 b of the void 1905 together. This process can be repeated for thesecond suture 1912 b to complete the repair, as shown in FIG. 20C. Thetissue augmentation constructs 1912 a, 1912 b can provide the manybenefits provided for herein, including but not limited to increasedsurface area through which forces from the sutures 1912 a, 1912 a can bedistributed, protection of a knot used to couple free ends of thesutures 1912 a, 1912 b, and providing a scaffold for new tissue to growto create a stronger repair between the edges 1930 a and 1930 b, withthe scaffold essentially becoming a new layer of tissue on top of theexisting rotator cuff tissue 1930.

FIG. 20D shows hip capsular tissue 1930′ having a void or gap 1905′.First and second sutures 1912 a′, 1912 b′ can be associated with firstand second constructs 1910 a′, 1910 b′ using techniques provided forthroughout the present disclosure. As shown in FIG. 20E, a first freeend of the first suture 1912 a′ can be threaded into the hip capsulartissue 1930′ on a first side of the void 1905′ and threaded back throughthe hip capsular tissue 1930′ on the opposite side of the void 1905′.The first free end can be tied to the second free end to bring edges1930 a′, 1930 b′ of the void 1905′ together. This process can berepeated for the second suture 1912 b′ to complete the repair, as shownin FIG. 20F. As with the tissue augmentation constructs 1912 a, 1912 b,the tissue augmentation constructs 1912 a′, 1912 b′ can provide the manybenefits provided for herein, including the highlighted benefitsprovided for with respect to the constructs 1912 a, 1912 b.

Tissue Augmentation Constructs—Collagen Tacks/Buttons

Another exemplary embodiment of a tissue augmentation construct isillustrated in FIGS. 21A and 21B. The tissue augmentation construct, asshown a tack or button 2010, has a generally cylindrical shape that isconfigured to be disposed on or otherwise associated with a suture 2012.More particularly, the tissue augmentation tack 2010 can have asubstantially cylindrical body with a bore or lumen 2014 extendingtherethrough from a proximal-most end 2010 p to a distal-most end 2010d. The bore 2014 can be used, for example, to receive the suture 2012 bymeans of a stitch 2013 so that the tack 2010 and suture 2012 can beassociated with each other, as described in greater detail below. Inalternative embodiments, the suture 2012 can be passed through the tack2010 without a pre-defined lumen being formed in a body of the tack2010, and/or the suture 2012 can be wrapped around or otherwise coupledto the tack 2010 without passing through it. As shown, the tack 2010 hasa height H_(T) that is less than a diameter D_(T). Further, the diameterD_(T) can be greater than a diameter of a filament or suture with whichthe tack 2010 is associated, e.g., the suture 2012, thereby increasingthe footprint of the suture 2012 and the surface area of tissueaugmentation of the system or device used in the surgical repair.

The suture 2012 can be any type of suture provided for herein orotherwise known to those skilled in the art. In the illustratedembodiment, the suture 2012 includes a self-locking mechanism 2015associated with an intermediate portion 2012 i of the suture 2012, acollapsible loop 2040 extending from one side of the self-lockingmechanism 2015, and fixed and tensioning tails 2012 f and 2012 textending from an opposite side of the self-locking mechanism 2015. Theself-locking mechanism 2015 can take a variety of forms, and in theillustrated embodiment it has a finger-trap-like configuration formed bypassing a first limb of the suture 2012 through a portion of a secondlimb of the suture 2012 before having the first limb exit the secondlimb to result in the fixed and tensioning tails 2012 f, 2012 t. Thefixed tail 2012 f can be wrapped around and/or coupled to the tack 2010,and as shown a stitch 2013 is used to help manage the fixed tail 2012and attach it to the tack 2010. The tensioning tail 2012 t can be usedto help adjust a diameter of the collapsible loop 2040.

The collapsible loop 2040 can be coupled to an implant, e.g., a boneanchor 2060, and a diameter of the loop 2040 can be adjusted by movingthe self-locking mechanism 2015 proximally away from the anchor 2060 anddistally towards the anchor 2060 as shown in the illustrated embodiment,for instance by applying a force proximally away from the anchor 2060 tothe tensioning tail 2012 t. The anchor 2060 can be a low profile anchorso that the anchor 2060 can more easily pass through tendon. A personskilled in the art will recognize various suitable low profile anchorsthat can be used in conjunction with the present disclosure, includingsome such anchors that are provided for above, e.g., Gryphon® and HealixTranstend™ anchors.

A number of other suture configurations are possible, including somedisclosed further below and others known to those skilled in the art.Some suture configurations that can be incorporated into this designinclude but are not limited to those disclosures provided for in U.S.Pat. No. 8,821,544, entitled “Surgical Filament Snare Assemblies,” andU.S. Pat. No. 9,060,763, entitled “Systems, Devices, and Methods forSecuring Tissue, the content of each which is incorporated by referenceherein in their entireties.

A person skilled in the art will recognize that the dimensions of theheight H_(T) and diameter D_(T) of the tissue augmentation tack 2010, aswell as a diameter of the bore 2014, can depend on a variety of factors,including but not limited to the size of the filament with which it isto be associated, the anatomy of the patient, and the type of procedurebeing performed. In some embodiments a ratio of the diameter D_(T) ofthe tack 2010 to a diameter of the suture limb 2012 can be approximatelyin the range of about 2:1 to about 100:1, and more particularly thediameter D_(T) can be at least three times greater than the diameter ofthe filament or suture with which the tissue augmentation tack 2010 isassociated in some instances. A variety of other sizes and shapes of thetissue augmentation tack 2010, including ratios of the dimensions of thetack and associated components (e.g., the suture 2012) can be utilizedwithout departing from the spirit of the present disclosure.

While ratios can be useful to help describe the relationship between thetack 2010 and the filament 2012, and the relationship between thedimensions of the tack 2010, some exemplary, non-limiting dimensions fora tissue augmentation tack can also be useful in understanding thepresent disclosure. As mentioned above, these dimensions can bedependent on a variety of factors. In some embodiments, the height H_(T)can be approximately in the range of about 1 millimeter to about 1centimeter, and the diameter D_(T) can be approximately in the range ofabout 1 millimeter to about 10 millimeters. The size of the diameter dof the bore 2014 can also depend on a variety of factors, including butnot limited to the size of the limb to be passed therethrough. In someembodiments, the diameter d can be approximately in the range of about0.5 millimeters to about 3 millimeters. Alternatively, bore 2014 may notbe present and the filament 2012 can be passed through the tack 2010without a bore. The tack 2010 can be made from any of the materialsprovided for above with respect to the other tissue augmentationconstructs, including but not limited to collagen.

In some embodiments, as shown in FIG. 21B, an inserter tool 2070 can beused to install the anchor 2060 in a trans-tendon approach into apreformed bone bore in a bone 2050. The inserter tool 2070 can have areleasable mechanism (not shown) at a distal end 2070 d that canreleasably engage the anchor 2060 such that after installation of theanchor into bone 2050, the inserter tool can be removed. For example,the releasable mechanism can be a compression fit, a thread to engagethe anchor 2060, a ball detent, or other releasable mechanisms that canbe associated with the inserter tool 2070 in view of the presentdisclosures or otherwise known by those skilled in the art.

In use, the inserter tool 2070 can be used to insert the anchor 2060through the tendon, or other soft tissue, 2030, as shown in FIG. 21C.The surgeon can then remove the inserter tool 2070 from the anchor 2060,after is has been secured into the bone 2050 below the tendon 2030, asshown in FIG. 21D. Once the anchor 2060 is secure in the bone 2050,tension can be applied to the tensioning tail in the direction T₁, asshown in FIG. 21E. As the tensioning tail 2012 t is pulled, the diameterof the suture loop 2040 is reduced and the tack 2010 is brought intocontact to the tendon 2030 to compress the tendon 2030 against the bone2050. The self-locking mechanism 2015 maintains a location of thetensioning tail 2012 t to keep the construct in a locked configuration.The tensioning tail can then be trimmed.

Numerous advantages result from the use of the tissue augmentation tack2010. As illustrated in FIG. 21E, the resulting configuration is one inwhich the tack 2010 is disposed on top of the tissue 2030, and there areno hard components and/or knots exposed. This decreases the possibilityof tissue abrasion, among other benefits. The same types of benefitsprovided for with other constructs provided for herein are also equallyapplicable. For example, when the tissue augmentation tack 2010 is madeof collagen or other types of tissue-growth-promoting materials, therepair can result in a tissue remodel such that no component but thesuture remains. Further, after the tack 2010 is advanced towards theanchor 2060 and secured at the tissue 2030, no suture management isreally required post-procedure.

Alternatively, if two tensioning tacks 2010 a, 2010 b are used, as shownin FIG. 21F, the tensioning tacks 2010 a, 2010 b can be installed in thesame manner as described above with regards to FIGS. 21A-21E. Instead oftrimming the tails 2012 t_1, 2012 t_2, the tensioning tails 2012 t_1,2012 t_2 can be secured into a lateral row anchor 2062 to providefurther compression of the tissue 2030 against the bone 2050. In afurther alternative method, as shown in FIG. 21G, the two tensioningtails 2012 t_1′ and 2012 t_2′ can be tied together with a knot 2018. Theknot 2018 can be covered by one or more additional tissue augmentationconstructs as provided for herein.

Other non-limiting alternative embodiments of the tack 2010 areillustrated in FIGS. 21H and 21I as tacks 2010′ and 2010″, respectively,the alternatives focusing on other types of self-locking mechanismsassociated with the respective sutures, 2012′, 2012″. The configurationof the suture 2012′ includes a self-locking sliding knot 2015′configured to selectively restrict the movement of the tensioning tail2012 t′ relative to the tack 2010′. A person skilled in the art willrecognize many different types of self-locking knots 2015′ that can beused in conjunction with the tack 2010′.

A further alternative tack 2010″ is shown in FIG. 21I. The tack 2010″has substantially the same dimensions as the tack 2010, and can be madeof substantially the same materials. The tissue augmentation tack 2010″,however, has two bores 2014 a″, 2014 b″ extending from a proximal mostsurface 2010 p″ to a distal-most surface 2010 d″. The two bores 2014 a″,2014 b″ can be parallel to one another, as shown in FIG. 21I, howeverother alternative configurations are contemplated. In some embodiments,no bores may exist and instead suture can be passed through or otherwiseassociated with the tack 2010″ as provided for herein or otherwise knownto those skilled in the art.

The suture 2012″ used in conjunction with the tack 2010″ can be similarto the suture 2012, but as shown it is manipulated into a configurationhaving two self-locking mechanisms 2015 a″ and 2015 b″ and two loops2040 a″ and 2040 b″. The self-locking mechanisms 2015 a″ and 2015 b″ canbe formed as described above or as otherwise known to those skilled inthe art. In the illustrated embodiment, the self-locking mechanisms 2015a″ and 2015 b″ have a finger-trap-like configuration formed by passing afirst limb of the suture 2012″ through a portion of a second limb of thesuture 2012″ before having the first limb exit the second limb to resultin fixed and tensioning tails 2012 f_1″, 2012 f_2″ and 2012 t_1″ and2012 t_2″. As shown, the fixed tails 2012 f_1″ and 2012 f_2″ can becoupled to the tack 2010″ using one or more stitches 2013″, andtensioning tails 2012 t_1″ and 2012 t_2″ can extend from theproximal-most end 20120 p″ of the tack 2010″. The loops 2040 a″ and 2040b″ can both be coupled to a suture implant, as shown an anchor 2060 a″,and as described above, the tensioning tails 2012 t_1″ and 2012 t_2″ canbe operable to adjust a diameter of the respective loops 2040 a″ and2040 b″. Although in the illustrated embodiment the self-lockingmechanisms 2015 a″ and 2015 b″ are shown as having a finger-trap-likeconfiguration, other types of self-locking mechanisms, including slidingknots, can be used in place of the illustrated self-locking mechanisms2015 a″ and 2015 b″.

Methods of Manufacturing Tissue Augmentation Constructs

The tissue augmentation constructs provided for herein can bemanufactured using a number of different techniques, some of which areprovided for below. Other techniques known to those skilled in the artor developed subsequent to the present disclosure, particularly in viewof the present disclosure, can also be used to manufacture the variousconfigurations of tissue augmentation constructs disclosed.

Methods of Manufacturing Tissue Augmentation Constructs—Blocks Having aTape Configuration

In one exemplary embodiment of making a tissue augmentation tape orstrip 10, the material being used to make the strip 10 can be cut into adesired shape. For example, in embodiments in which the strip is beingmanufactured from either autograft tissue, allograft tissue, orxenograft tissue, if the tissue is harvested prior to the procedure, thefresh tissue can be cut into the desired shape, e.g., for the strip 10,a generally rectangular shape having a length L, a width W, and athickness T as shown in FIG. 1A. Whether the strip is made fromharvested material or not, acquisition of the material to make the stripcan be achieved using any techniques known to those skilled in the art.In accordance with the present disclosure, the tape or strip 10 can haveany shape, for example the tissue can be cut into an oval shape, acircular shape, a triangular shape, etc. Further, the tissue need not becut with a traditional scalpel or scissors. In some instances it can besized with the use of a punch, a computer numerical control machine, alaser cutter, or other known manufacturing techniques.

Once the tissue is formed into the desired shape, a threader can beassociated with the strip 10. For example, similar to the suture limb 12a as shown in FIG. 1B, an intermediate filament portion 210 of thethreader 206 can be threaded through the strip 10 with the use of arunning stitch. The stitch can pass back-and-forth across the body ofthe tape strip 10 as many times as desired. In alternative embodiments,the intermediate filament portion 210 of the threader 206 can just passfrom one of the tape strip 10 to the other without ever passing out ofthe body. After the threader 206 has been installed, the strip 10 can bedried for packaging. Alternatively, the threader 206 can be insertedafter the tissue has been dried. Further, the strip 10 need not bedried.

Methods of Manufacturing Tissue Augmentation Constructs—Blocks HavingTube Configurations

An exemplary embodiment for making a tissue augmentation tube 110 isillustrated in FIGS. 22A-22C. The material being used to make the tube110 can be harvested or otherwise acquired using techniques known tothose skilled in the art. The material can then be shaped using any ofthe techniques described above with respect to the strip 10, elsewhereherein, or otherwise known to those skilled in the art. As shown in FIG.22A, a piece of material 120 can be harvested having a length U and awidth W′. The width W′ can be equal to approximately D*π, were D is thediameter of the tube 110, as shown in FIG. 2B. As shown in FIG. 22A, thepiece of material 120 can be generally rectangular, having a first end120 a and a second end 120 b with the width W′ extending therebetween.Alternatively, the piece of material 120 can have any shape.

Once the piece of material 120 has been cut out, the first and secondends 120 a, 120 b can be brought proximate to one another andsubsequently attached to one another, thereby forming a tube. As shownin FIGS. 22B and 22C, the first and second ends 120 a, 120 b areattached using a suture, or filament, 122 to stitch the ends together.Alternatively, the first and second ends 120 a, 120 b can be attached toone another with the use of glue, collagen bond, staples, light curing,crosslinking, mechanical interlock, dehydration, or other techniques forattaching soft tissue to soft tissue known to those skilled in the art.A threader 206 can be inserted into the tube 110 before the two ends 120a, 120 b are attached, or after. The tube 110 can be dried forpackaging. Alternatively, the tube 110 can be maintained in a hydratedform, without dehydrating the block 110 (this is the case with anyconstruct discussed herein or otherwise derivable therefrom). Analternative method for manufacturing a tissue augmentation tube isprovided for in FIGS. 23A-23C. In this method, multiple tubes 110 a-110c can be made at a time from a single material, or as shown two piecesof material, one piece disposed above the other.

As shown, a first piece of material 130 a and a second piece of material130 b are placed one on top of the other. Similar to earlierembodiments, the material 130 a, 130 b can be acquired, sized, andshaped using any techniques provided for herein or otherwise known tothose skilled in the art. As shown in FIG. 23B, first and second piecesof material 130 a, 130 b can have a length L′ and a width that isdetermined as a function of the number of tubes 110 a-110 c desired.Specifically, each tube 110 has a diameter, or width, D, as noted above.Therefore, the piece of material can have a width that is equal to thenumber of tubes 110 desired multiplied by D. Alternatively, themanufacturing can be planned to allow for a select amount of space to beformed between each strip that is formed. In some embodiments, a singlepiece of material (not shown) having a generally rectangular shape canbe used, with the piece being folded in half to create a first piece ofmaterial and a second piece of material as shown, one layered upon theother.

Once the two pieces of material 130 a, 130 b have been cut to thedesired size, pins 132 a-132 c can be placed therebetween. The pins 132a-132 c can be placed approximately parallel to one another andperpendicular to a long edge 131 of the material. The pins 132 a-132 ccan be spaced such that there is sufficient space between each pin 132a-132 c to allow for attachment and separation of the individual tubes110 a-110 c.

As shown in FIGS. 23A-23C, the first and second pieces of material 130a, 130 b are attached using sutures 134 to stitch the two piecestogether to form a tube around the pin 132 a. Alternatively, the firstand second pieces of material 130 a, 130 b can be attached to oneanother with the use of glue, collagen bond, staples, light curing, orother known techniques. Once all of the tubes 110 a-110 c have beenstitched, the individual tubes 110 a-110 c can be cut along lines L₁ andL₂. The lines L₁ and L₂, as shown in FIG. 23B, are approximatelyparallel to the pins 132 a-132 c. Once the individual tubes 110 a-110 chave been cut, the pins 132 a-132 c can be removed, as shown in FIG.23C, leaving a bore or lumen 114 a. A threader 206 can be associatedwith the lumen 114 a in manners provided for herein with respect to thelumen 114 of the tube 110 to pass a suture limb through the lumen.

This methods of manufacturing tubular constructs can also be used insimilar manners to manufacture cannulated constructs like the bars 3010,3110 illustrated in FIGS. 2E and 2F. In such instances, the pins 132a-132 c can be removed once the cannulations are formed using them, andthe two layers of material 130 a′, 130 b′ can be lightly compressed, orcan relax by themselves, towards each other. As a result, the lumen 114a′ can transform from a tubular shape, as shown in FIG. 23C, to a slitshaped lumen 114 a′, as shown in FIGS. 2E and 2F. As described above,the overall shape of the construct 3010, 3110 can be generallyrectangular prisms. In the construction of the construct 3010, 3110, forexample, the use of pins 132 a′-132 c′ may be omitted altogether.Alternatively, the pins 132 a′-132 c′ may be replaced with skewerblades, not shown, so that the shape of the lumen 114 c′ starts as aslit rather than starting with a tubular shape.

A further alternative method for manufacturing a tissue augmentationtube is provided for in FIGS. 24A-24C. This method also allows formultiple tube 110 a′-110 c′ to be made at a time from a single material,or from multiple pieces of material if desired. As shown, a piece ofmaterial 130′ can have a length L″ and a width that is determined basedupon the number of tubes desired. Specifically, each tube 110 a′-110 c′has a diameter, or width, D′. Therefore, the piece of material can havea width that is equal to the number of augmentation blocks 110′ desiredmultiplied by D′. Alternatively, the width can include an additionalspace X between each tube 110′, which can be accounted for when formingthe size of the piece of material 130′. As with any of the embodimentsprovided for herein, a thickness of the material can vary, depending ona variety of factors, including but not limited to the size and shape ofthe other components and tissue with which the tube is being used, theanatomy of the patient, and the type of procedure being performed. Insome exemplary embodiments, a thickness T′ as illustrated in FIG. 24A,can be approximately in the range of about 0.5 millimeter to about 10millimeters.

Once the piece of material 130′ has been cut to the desired size, pins132 a′-132 c′ can be inserted through the piece of material 130′ from afirst edge 130 a′ to a second edge 130 b′. The pins 132 a′-132 c′ can beinserted such that they are approximately parallel to one another andapproximately perpendicular to the first and second edges 130 a′, 130 b′of the material 130′. The pins 132 a′-132 c′ can be spaced such thatthere is sufficient space between each pin 132 a′-132 c′ to allow forseparation. The pins 132 a′-132 c′ can be sized to have a diameter thatis approximately equal to the diameter of the resulting lumen 114″.

Alternatively, as shown in FIG. 25, a trocar 2802 can be used to form alumen 114″ in a piece of material. Trocars are generally known to thoseskilled in the art, and thus a detailed description related to trocarsis unnecessary. In fact, in the illustrated embodiment, only a distalend of the trocar 2802 is shown, the distal end including a tip 2804 anda shaft 2806 with which the tip 2804 is associated, e.g., coupled. Adistal-most end of the tip 2804 is pointed and sharp, and is thusconfigured to puncture tissue. The shaft 2806 of the trocar distallyextends from a housing (not shown) to help guide the trocar in thematerial.

The trocar 2802 is unique in comparison to other trocars because theshaft 2806 has a gradually increasing diameter in a proximal directionP, i.e., towards the housing. More particularly, the tip 2804 has a,substantially constant, diameter D_(P1) approximately in the range ofabout 0.10 millimeters to about 1 millimeter, with, as shown, thedistal-most tip having a diameter that is even smaller than D_(P1). Theshaft 2806 has a gradually increasing diameter, starting from the firstdiameter D_(P1) and terminating at a second diameter D_(P2)approximately in the range of about 0.5 millimeters to about 5millimeters. Other dimensions are certainly possible, depending, atleast in part, on the desired lumen size, the instruments with which thetrocar will be used, and surgeon preference.

The gradually increasing diameter of the shaft 2806 allows for moreprecise lumen formation in tissue. By starting with a trocar having ashaft that has a smaller diameter proximate to the distal tip 2804, itis easier to position and advance the trocar 2802 in soft biologicaltissue. In use, the tip 2804 can be positioned, for example, on thefirst edge of a piece of material and advanced by applying pressureand/or twisting the trocar 2802 as it is advanced towards a second sideof the tissue to form an initial lumen. As the trocar 2802 is advanceddistally towards the second side, a size of the opening that it formsincreases gradually, from D_(P1) to D_(P2). This is different thantypical trocars, which generally have a single size shaft associatedwith a distal tip.

Turning back to FIGS. 24A-24C, once all of the pins 132 a′-132 c′ havebeen inserted, the individual tubes 110 a′-110 c′ can be cut along linesC₁-C₆. The lines C₁-C₆, as shown in FIG. 24B, are approximately parallelto the pins 132 a′-132 c′. Once the individual tubes 110 a′-110 c′ havebeen cut, the pins 132 a′-132 c′ can be removed, as shown in FIG. 24C,leaving a lumen 114 a′. A threader 206 can be associated with the lumen114 a′ in manners provided for herein.

The methods of manufacture illustrated herein need not be performed inthe order prescribed. For example, with respect to the methods of FIGS.23A-23C and FIGS. 24A-24C, the pins 132 a-132 c and 132 a′-132 c′ can beremoved before the tubes 110 a-110 c and 110 a′-110 c′ are cut apart.Further, the tubes 110 a-110 c and 110 a′-110 c′ can be dried at anysuitable point during the manufacturing process. Moreover, this processcan be used to create any number of blocks having any number of shapesor configurations, including but not limited to tubular or rectangular,for example a single tissue augmentation block 110 a and 110 a′, twoaugmentation blocks, or more than three augmentation blocks. Stillfurther, the manufacturing technique provided for with respect tovarious manufacturing embodiments can be modified in view of the presentdisclosures to manufacture other tissue augmentation constructs. By wayof non-limiting example, blocks having a tape or strip configuration canbe formed in view of the present disclosures, thereby allowing multiplestrips to be formed from a single piece of material and/or multiplepieces of material stacked on top of each other if such additionalthickness and/or additional material is desired. The techniques canlikewise be adapted for forming augmentation washers, such as by formingthe disclosed blocks 110, 3010, or 3110, and then cutting them alongtheir length to form washers.

Methods of Manufacturing Tissue Augmentation Constructs—Coring

In some embodiments of the various tissue augmentation constructsdisclosed, including blocks, strips, tubes, bars, washers, patches, andtacks, one or more lumens or cannulations may be formed in a body of theconstruct. Some techniques for forming such lumens that involve usingpins are provided above. Another exemplary technique for creating suchlumens involves coring, as shown and described with respect to FIGS.26A-26I.

As shown in FIG. 26A, a precut portion of a construct 2110 having alength L₁ and a width W₁ can be prepared to be cored. A tool can be usedto core the construct 2110, such as a coring tube 2132. The coring tube2132 can have a handle 2134 at a proximal end and a hollow tube 2136 ata distal end. The hollow tube 2134 of the coring tube 2132 can have adistal edge 2138 that can be sharpened or serrated to create a cleancut. The hollow tube 2134 can have a diameter d₁ that is less than theW₁ of the construct. The diameter d₁ can be chosen based on the suturesize desired for a given procedure.

As shown in FIG. 26B, the coring tube 2132 can be advanced in thedirection S while being rotated in the direction R. The rotation andlinear translation of the tool 2132 can provide for a cleaner cut;however, the tool can be pushed through only in the direction S, withoutany rotation. As shown in FIG. 26C, once the distal end of the coringtube 2132 has been advanced along the entire length of the construct2110, it can be removed in an opposite direction S′, thereby removingthe portion of material 2110 a and leaving a circular lumen 2114. Asshown in FIG. 26D, a plurality of lumens 2114 a-2114 c can be created ina single construct 2110. Alternatively, the construct of FIG. 26D can becut into strips that run parallel to the lumens 2114 a-2114 c, therebyforming multiple constructs with each including only one lumen. In afurther alternative embodiment, as shown in FIGS. 26E and 26F, at leasttwo bores 2114 d, 2114 e can be created in a construct 2110 such thatthey intersect at some location 2120 in the construct.

In alternative coring embodiments, illustrated in FIGS. 26G-26I, acurved lumen 2114′ can be created using the coring tube 2132′. As shownin FIG. 26G, a generally U-shaped construct 2110′ having first andsecond generally curved shaped edges 2110 a′, 2110 b′ and two straightedges 2110 c′, 2110 d′, is prepared to be cored. Similar to theembodiment of FIG. 26A-26C, a coring tube 2132′ is used to core out alumen 2114′ through the construct that enters and exits along edge 2110a′. In FIG. 26H, the lumen 2114′ is shown as being substantially linear.Once the lumen 2114′ has been created, the construct can be stretched,or otherwise rearranged, such that the edges 2110 a′-d′ are allsubstantially straight to create a generally rectangular construct2110′, as shown in FIG. 26I.

Method of Manufacturing Tissue Augmentation Constructs—Tunneling Station

In a further alternative method of manufacturing, a construct formationtunneling station is provided. As shown in FIG. 27A, a constructformation tunneling station 3200 can include a stage 3220 for holding atissue augmentation construct, a lumen formation tool 3224 for forming alumen in the construct, and a guide 3228 for helping to locate the lumenformation tool 3224 with respect to the construct being held by thestage 3220.

In an exemplary embodiment, the construct stage 3220 can support andguide a piece of material 3230 from which constructs can be formed. Theconstruct stage 3220 can be a self-centering compression stage tomaintain a piece of material 3230 at a fixed height through the stage3220. The self-centering of the construct stage 3220 can be accomplishedaccording to accepted manufacturing techniques. The construct stage 3220can include two stages 3220 a, 3220 b which are able to move towards andaway from one another, Y1, Y2 to self-center and compress the material3230. Alternatively, only one stage 3220 a, 3220 b can translate, or thestages 3220 a, 3220 b can be fixed relative to one another. The firststage 3220 a can have a distal face 3219 a that is opposed to theproximal face 3219 b of the second stage 3220 b. Each of the distal face3219 a and the proximal face 3219 b can include semi-circular reliefs3221 a, 3221 b that are able to accommodate the material 3230 uponinsertion of the lumen formation tool 3222, as shown in FIGS. 27B and27C. The construct stage 3220 can include mechanisms, not shown, toadvance the material 3230 in a direction Z to automate the manufacturingprocess, for instance, as described below with respect to FIG. 27J.

The construct formation tunneling station 3200 can include a lumenformation tool 3224 that can include a guide 3228 and a cutting tool3222. In the illustrated embodiment, the guide 3228 can generallyinclude a lumen 3227 and can be fixed relative to the construct stage3220 by connectors 3226 a, 3226 b to ensure that the relativeorientation of the tool 3224 and the stage 3220 remains fixed such thatthe orientation of the lumen within a construct formed by the jigstation 3200 is within accepted manufacturing tolerances from constructto construct. Alternatively, the guide 3228 can be secured to the stage3220 with only one connector, or more than two connectors. Further,while the lumen forming tool 3224 is shown physically connected to theconstruct stage 3220, alternatively, the tool 3224 and the stage 3220can be separate pieces that are fixed relative to one another, e.g.,attached to the same work table, to ensure proper lumen formingalignment.

A cutting tool 3222 can be disposed within the guide 3228, including bybeing removably and replaceably associated with the guide 3228, suchthat the tool 3222 can freely rotate R and translate X within the guide3228. In some embodiments, the tool 3222 can be a needle as shown inFIG. 27D. Alternatively, the cutting tool can be a spear, as shown inFIG. 27E, for example a Premier Edge MVR knife available from OasisMedical of Glendora, Calif. The spear can include a proximal stemportion 3222 p having a substantially circular cross sectional shape anda distal spear portion 3222 d. The distal spear portion can have aplurality of straight sharp edges 3223. The plurality of straight sharpedges 3223 can have a smooth transition from the proximal stem portion3222 p of the tool.

In further alternative embodiments the cutting tool 3222 can have anumber of alternative designs. For example, a trocar as shown in FIG.27F, a drill bit as shown in FIG. 27G, a coring tube as shown in FIG.27H, or a straight blade as shown in FIG. 27I. Each of the alternativetools can be used to create a lumen within a construct 3210 according toaccepted manufacturing techniques provided for throughout the presentdisclosure.

In an exemplary method of use, multiple tubes 3210 a-3210 d can be madeat a time from a single length of material, or from multiple pieces ofmaterial if desired. As shown, a piece of material 3230 can have alength L and a width W. The width W of the material can be the length ofthe resulting construct while the length L can be determined based uponthe number of constructs desired. Specifically, each construct 3210a-3210 d has a diameter, or width, D. Therefore, the piece of materialcan have a length L that is equal to the number of constructs 3210desired multiplied by D. Alternatively, the length L can include anadditional space between each construct 3210, which can be accounted forwhen forming the size of the piece of material 3230. As with any of theembodiments provided for herein, a thickness of the material can vary,depending on a variety of factors, including but not limited to the sizeand shape of the other components and tissue with which the construct isbeing used, the anatomy of the patient, and the type of procedure beingperformed.

Once the piece of material 3230 is advanced into the stage 3220, thelumen forming tool 3224 can be actuated such that the cutting tool 3222can be inserted through the piece of material 3230 from a first edge3230 a to a second edge 3230 b, as shown in FIGS. 27I-K. Depending onthe type of cutting tool 3222 used, the lumen forming tool 3224 caneither translate the tool 3222 in a direction X, or rotate and translatethe tool 3222 in the directions X and R into the material 3230.Actuation of the cutting tool 3222 can be performed automatically withan actuator. Alternatively, the cutting tool 3222 can be manuallyactuated by a user. The cutting tool 3222 can then be retracted leavinga lumen 3214 a-3214 c. The material 3230 can then be advanced, in thedirection Z, a predetermined distance and the process can be repeated tocreate additional constructs. Individual constructs 3210 a-3210 d canthen be separated from the piece of material 3230 as shown in FIGS. 27Kand 27L. For example, the individual constructs 3210 a-3210 d can beseparated by means of a punch 3290 a-3290 d or other cutting mechanismsas provided for throughout the present disclosure.

An alternative construct forming jig station 3200′, as illustrated inFIG. 27M, can provide for parallel lumen formation. As shown in FIG.27M, the stage 3220′ can accommodate a larger length L′ of the material3230′. For example, as illustrated in FIG. 27M, the stage 3220′ canaccommodate a length required to create three constructs. Alternatively,the stage 3220′ can extend to accommodate any number of constructs. Thestage 3220′ can, similar to the stage of the jig station 3200, havesemi-circular reliefs and can be self-centering. Similar to theembodiment of FIGS. 27A-27L, the station 3220′ can include a pluralityof lumen forming tools 3224 a′, 3224 b′, 3224 c′ that are each alignedin parallel with each other. Alternatively, the plurality of tools 3224a′, 3224 b′, 3224 c′ can be oriented at any angle relative to oneanother. The lumen forming tools 3224 a′, 3224 b′, 3224 c′ are alignedsuch that each of the respective cutting tools 3222 a′, 3222 b′, 3222 c′each translate towards the stage in parallel directions. In theillustrated embodiment three lumen forming tools 3224 a′, 3224 b′, 3224c′ are shown, however any number of lumen forming tools can be providedfor. After each of the lumen forming tools 3224 a′, 3224 b′, 3224 c′have been actuated and retracted to create lumens 3214 a′, 3214 b′, 3214c′ in the material 3230′, the material 3230′ can be advanced in thedirection D′. The individual constructs 3210 a′, 3210 b′, 3210 c′ can beseparated according to techniques provided for herein. Alternatively,constructs that include a plurality of lumens can be cut from thematerial to form patches or scaffolds, as discussed further below.

Methods of Manufacturing Tissue Augmentation Constructs—General Methods

The embodiments described above represent some specific techniquesassociated with manufacturing blocks having particular configurations,e.g., strips, tubes, bars, and washers. More general techniques such ascoring are also provided. Such techniques can be adapted by a personskilled in the art for use in other configurations of tissueaugmentation constructs in view of the present disclosures. Stillfurther, the present disclosure provides for even more generaltechniques and methods that can be used to form the various tissueaugmentation constructs disclosed herein derivable from the presentdisclosures. The methods provided for in this section can be used asstandalone methods, in conjunction with each other, and/or inconjunction with the other manufacturing techniques provided for in thepresent disclosure.

In some embodiments, the constructs can be fully, or partially,manufactured by phase separation techniques, lyophilization, knitting,weaving, electrospinning, rapid prototyping (e.g., 3-D printing) orcombinations of thereof. In order to facilitate tissue in growth,perforations can be created in the construct using thermal, electrical,or/and mechanical means, among others. For example, the perforations canbe created by a laser or a sharp object such as a needle, punch, or die.The size of a perforation can be any suitable size, but preferably, theperforations are sized to allow tissue in-growth. More preferably, theperforations size can be approximately in the range of about 50 micronsto about 2000 microns, and even more preferably, approximately in therange of about 50 microns to about 1000 microns.

In some embodiments, a biological tissue including, but not limited to,an allograft or xenograft tissue, may, optionally, be incorporatedwithin the various tissue augmentation constructs, thus forming atwo-layer construct. The combination of a biological tissue within thevarious tissue augmentation constructs can provide for enhancedbiological performance and mechanical performance of a resultingconstruct.

For example, as shown in FIG. 28, a construct 2710 (as shown a patch orscaffold, which is described in greater detail below) can include areconstituted collagen matrix or a biodegradable polymer, 2702 or any ofthe other materials described herein for use in a tissue augmentationconstruct (e.g., autograft, xenograft, pulverized collagen pieces,porcine dermis, etc.), and a biological component, such as anextracellular matrix (ECM) 2704, attached to one side of the matrix 2702using techniques known to those skilled in the art. The reconstitutedcollagen matrix or biodegradable polymer can be, or can be part of, afirst layer, and the biological component can be, or can be part of, asecond layer, with a thickness and a surface area of the first layerbeing larger, and as shown substantially larger, than a thickness and asurface area of the second layer. In other embodiments, the biologicalcomponent, e.g., the ECM 2704, can be disposed on opposed sides of thematrix 2702 and/or coated or soaked onto the matrix 2702. A personskilled in the art will recognize a number of different attachmentoptions that can be used to couple the ECM(s) 2704 to the matrix 2702,including but not limited to gluing and stitching. The inclusion of theECM 2704 or other biological component can help integrate theaugmentation construct with the tissue with which the construct is beingused. In one exemplary embodiment, the matrix 2702 can have a thicknessT₁ approximately in the range of about 1 millimeter to about 4millimeters, and the ECM layer can have a thickness approximately in therange of about 80 microns to about 3 millimeters.

In some embodiments, a biological component can be coated onto thetissue augmentation construct, or incorporated in the tissueaugmentation construct. If a biological component is coated onto thetissue augmentation construct, the biological component is preferablyassociated with at least a portion of the construct. For example, thebiocompatible construct can include an adhesion agent for anchoring thesuspension of the biological component to a scaffold. The adhesion agentcan be an anchoring agent, a cross-linking agent (i.e., chemical orphysical), and combinations thereof. Suitable anchoring agents caninclude, for example, hyaluronic acid, fibrin glue, fibrin clot,collagen gel, alginate gel, gelatin-resorcin-formalin adhesive,mussel-based adhesive, dihydroxyphenylalanine (DOPA) based adhesive,chitosan, transglutaminase, poly(amino acid)-based adhesive,cellulose-based adhesive, polysaccharide-based adhesive, syntheticacrylate-based adhesives, platelet rich plasma (PRP), platelet poorplasma (PPP), clot of PRP, clot of PPP, Matrigel, Monostearoyl Glycerolco-Succinate (MGSA), Monostearoyl Glycerol co-Succinate/polyethyleneglycol (MGSA/PEG) copolymers, laminin, elastin, proteoglycans, andcombinations thereof.

Cross-linking can be achieved using physical means and chemical agents.Examples of chemical agents used to cross-link can includedehydrothermal (DHT) treatment, divinyl sulfone (DVS), polyethyleneglycol divinyl sulfone (VS-PEG-VS), hydroxyethyl methacrylate divinylsulfone (HEMA-DIS-HEMA), formaldehyde, glutaraldehyde, aldehydes,isocyanates, alkyl and aryl halides, imidoesters, N-substitutedmaleimides, acylating compounds, carbodiimide, hexamethylenediisocyanate, 1-Ethyl-3-[3-dimethylaminopropyl]carbodiimidehydrochloride (EDC or EDAC), hydroxychloride, N-hydroxysuccinimide,light (e.g., blue light and UV light), pH, temperature, and combinationsthereof.

The biological components can be one or more effectors that promotehealing and/or regeneration of the affected tissue at the site ofinjury. The biological component of a construct can include heterologousor autologous growth factors, proteins, matrix proteins, peptides,antibodies, antibiotics, anti-inflammatories, therapeutic agents,chemotactic agents, antimicrobial agents, antibiotics, anti-inflammatoryagents, compounds that minimize or prevent adhesion formation, compoundsor agents that suppress the immune system, cell attachment mediators,biologically active ligands, integrin binding sequence, enzymes,cytokines, glycosaminoglycans, polysaccharides, viruses, virusparticles, nucleic acids, analgesics, cells, platelets, platelet richplasma (PRP), minced extracellular particles, minced tissue fragments,hydroxyapatite, tricalcium phosphate, bioactive glass, biphasic calciumphosphate, calcium sulfate, other bone and/or tissue growth-promotingmaterials, and combinations thereof.

As described herein, in some embodiments the tissue augmentationconstruct can have one or more through holes or bores extendingtherethrough. The through hole(s) can be a slit or a passage withdifferent cross-sectional shapes, for example, circular, elliptical,square, rectangular, etc. The through hole(s) can be created by any toolthat can remove materials including mechanical, thermal, or electricaltools. Alternatively, the through hole(s) can be a slit(s) that can becreated by any tool that results in the separation of two surfaces.

In some embodiments, the construct can be made of more than one layer.The layers of the construct can be made of the same material ordifferent materials. The layers can be bonded or fused together usingsutures, mechanical, electrical, and chemical fastening techniques.Examples of bonding or fusing can include, for example, tissue welding,staples, rivets, tissue tacks, darts, screws, pins, arrows,cross-linking, vacuum pressing, compression, compression combined withdehydration, vacuum pressing combined with dehydration, or a biologicaladhesive or a combination of thereof. Dehydration in this context caninclude, for example, freeze-drying (i.e., lyophilization). Biologicaladhesives can include, for example, fibrin glue, fibrin clot, collagengel, alginate gel, gelatin-resorcin-formalin adhesive, mussel-basedadhesive, dihydroxyphenylalanine (DOPA) based adhesive, chitosan,transglutaminase, poly(amino acid)-based adhesive, cellulose-basedadhesive, polysaccharide-based adhesive, synthetic acrylate-basedadhesives, platelet rich plasma (PRP), platelet poor plasma (PPP), clotof PPP, Matrigel, Monostearoyl Glycerol co-Succinate (MGSA),Monostearoyl Glycerol co-Succinate/polyethylene glycol (MGSA/PEG)copolymers, laminin, elastin, hyaluronic acid, proteoglycans, andcombinations thereof.

In some embodiments the construct can include a reinforcing material.The reinforcing material can be comprised of any absorbable ornon-absorbable textile having, for example, woven, knitted, warpedknitted (i.e., lace-like), non-woven, and braided structures. In oneembodiment, the reinforcing material can have a mesh-like structure.Mechanical properties of the material can be altered by changing thedensity or texture of the material, the type of knit or weave of thematerial, the thickness of the material, or by embedding particles inthe material.

Mechanical properties of the reinforcing material can additionally bealtered by creating sites within the construct where fibers arephysically bonded with each other or physically bonded with anotheragent, such as, for example, an adhesive or a polymer. The fibers usedto make the reinforcing component can be, for example, monofilaments,yarns, threads, braids, or bundles of fibers. These fibers can be madeof any biocompatible material including, but not limited to,bioabsorbable materials such as polylactic acid (PLA), polyglycolic acid(PGA), polycaprolactone (PCL), polydioxanone (PDO), trimethylenecarbonate (TMC), copolymers or blends thereof. The fibers can also bemade from any biocompatible materials based on natural polymersincluding silk and collagen-based materials. Alternatively, the fiberscan also be made of any biocompatible fiber that is nonresorbable, suchas, for example, polyethylene, nylon, polyester, polyethyleneterephthalate, poly(tetrafluoroethylene), polycarbonate, polypropylene,polyurethane, and poly(vinyl alcohol).

In another embodiment, the construct may incorporate hydroxyapatite,tricalcium phosphate, Bioglass, biphasic calcium phosphate, calciumsulfate, other bone-promoting materials within the whole construct orlocalized in a portion of the construct where bone regeneration isdesired. Bioglass is a silicate containing calcium phosphate glass, orcalcium phosphate glass with varying amounts of solid particles added tocontrol resorption time. Bioglass is one example of materials that canbe spun into glass fibers and used as a reinforcing material. Bioglasscan also be incorporated into the construct in a powder form. Suitablesolid particles may be added include iron, magnesium, sodium, potassium,and combinations thereof.

In some embodiments, both the biocompatible construct and thereinforcing material may be formed from a thin, perforation-containingelastomeric sheets with pores or perforations to allow tissue in-growth.A sheet can be made of blends or copolymers of polylactic acid (PLA),polyglycolic acid (PGA), polycaprolactone (PCL), and polydioxanone(PDO).

The construct can be formed partially or completely from a polymericfoam component, having pores with an open cell pore structure. The poresize can vary, but preferably, the pores are sized to allow tissuein-growth. In some embodiments, the pore size is approximately in therange of about 40 microns to about 1000 microns, and in otherembodiments, the pore size is approximately in the range of about 50microns to about 500 microns. The polymeric foam component can be madefrom natural or/and synthetic materials, such as reconstituted collagen.The polymeric foam can be non-crosslinked or crosslinked. The polymericfoam component can, optionally, contain a reinforcing component, such asfor example, textiles as discussed above. In some embodiments, thepolymeric foam component can contain a reinforcing component which canbe integrated with the reinforcing component such that the pores of thefoam component penetrate the mesh of the reinforcing component andinterlock with the reinforcing component.

In some embodiments the polymeric foam component of the tissue implantmay be formed as a foam by a variety of techniques well known to thosehaving skill in the art. For example, the polymeric starting materialsmay be foamed by lyophilization, supercritical solvent foaming, which isdescribed at least in European Patent Application No. 464,163, thecontents of which is incorporated by reference herein in its entirety,gas injection extrusion, gas injection molding or casting with anextractable material (e.g., salts, sugar, or similar suitablematerials).

A polymeric foam component of engineered tissue repair implant devicesof the present disclosure may be made by a polymer-solvent phaseseparation technique, such as lyophilization. A polymer solution can beseparated into two phases by any one of the four techniques: (a)thermally induced gelation/crystallization; (b) non-solvent inducedseparation of solvent and polymer phases; (c) chemically induced phaseseparation, and (d) thermally induced spinodal decomposition. Thepolymer solution can be separated in a controlled manner into either twodistinct phases or two bi-continuous phases. Subsequent removal of thesolvent phase usually leaves a porous structure with a density less thanthe bulk polymer and pores in the micrometer ranges. Additionalinformation about the solvent phase is provided in Microcellular Foamsvia Phase Separation, J. Vac. Sci. Technol., A. T. Young, Vol. 4(3),May/June 1986, the contents of which is incorporated by reference hereinin its entirety.

The steps involved in the preparation of these foams include, forexample, choosing the right solvents for the polymers to be lyophilizedand preparing a homogeneous solution. Next, the polymer solution can besubjected to a freezing and vacuum drying cycle. The freezing step phasecan separate the polymer solution and vacuum drying step can remove thesolvent by sublimation and/or drying, leaving a porous polymer structureor an interconnected open cell porous foam. Suitable solvents that maybe used in the preparation of the foam component can include, forexample, formic acid, ethyl formate, acetic acid, hexafluoroisopropanol(HFIP), cyclic ethers (e.g., tetrahydrofuran (THF), dimethylene fluoride(DMF), and polydioxanone (PDO)), acetone, acetates of C2 to C5 alcohols(e.g., ethyl acetate and t-butylacetate), glyme (e.g., monoglyme, ethylglyme, diglyme, ethyl diglyme, triglyme, butyl diglyme and tetraglyme),methylethyl ketone, dipropyleneglycol methyl ether, lactones (e.g.,γ-valerolactone, δ-valerolactone, β-butyrolactone, γ-butyrolactone),1,4-dioxane, 1,3-dioxolane, 1,3-dioxolane-2-one (ethylene carbonate),dimethlycarbonate, benzene, toluene, benzyl alcohol, p-xylene,naphthalene, tetrahydrofuran, N-methylpyrrolidone, dimethylformamide,chloroform, 1,2-dichloromethane, morpholine, dimethylsulfoxide,hexafluoroacetone sesquihydrate (HFAS), anisole, and mixtures thereof.Among these solvents, one exemplary solvent is 1,4-dioxane. Ahomogeneous solution of the polymer in the solvent is prepared usingstandard techniques.

The applicable polymer concentration or amount of solvent that may beutilized can vary with each system. In one embodiment, the amount ofpolymer in the solution can vary from about 0.5% to about 90% by weight.In another embodiment, preferably, the amount of polymer in the solutioncan vary from about 0.5% to about 30% by weight. The amount of polymerin the solution can vary depending on factors such as the solubility ofthe polymer in a given solvent and the final properties desired in thefoam.

In embodiments of the construct that include a polymeric foam, solidsmay be added to the polymer-solvent system to modify the composition ofthe resulting polymeric foam surfaces. As the added particles settle outof solution to the bottom surface, regions will be created that willhave the composition of the added solids, not the foamed polymericmaterial. Alternatively, the added solids may be more concentrated indesired regions (i.e., near the top, sides, or bottom) of the resultingtissue augmentation construct, thus causing compositional changes in allsuch regions. For example, concentration of solids in selected locationscan be accomplished by adding metallic solids to a solution placed in amold made of a magnetic material (or vice versa).

A variety of types of solids can be added to the polymer-solvent system.In one embodiment, the solids are of a type that will not react with thepolymer or the solvent. The added solids can have an average diameter ofless than about 2 millimeters. In other embodiments, added solids canhave an average diameter of about 50 microns to about 1000 microns. Thesolids can be present in an amount such that they will constitute fromabout 1 volume to about 50 volume percent of the total volume of theparticle and polymer-solvent mixture (wherein the total volume percentequals 100 volume percent).

Exemplary solids include, for example, particles of demineralized bone,calcium phosphate particles, Bioglass particles, calcium sulfate, orcalcium carbonate particles for bone repair, leachable solids for porecreation and particles of bioabsorbable natural polymers, bioabsorbablesynthetic polymers, non-bioabsorbable materials, minced extracellularparticles, minced tissue fragments, or any biocompatible materials thatis not soluble in the solvent system.

Exemplary leachable solids include, for example, nontoxic leachablematerials such as salts (e.g., sodium chloride, potassium chloride,calcium chloride, sodium tartrate, sodium citrate, and the like),biocompatible mono and disaccharides (e.g., glucose, fructose, dextrose,maltose, lactose and sucrose), polysaccharides (e.g., starch, alginate,chitosan), water soluble proteins (e.g., gelatin and agarose). Leachablematerials can be removed by immersing the foam with the leachablematerial in a solvent in which the particle is soluble for a sufficientamount of time to allow leaching of substantially all of the particles.The solvent can be chosen so that it does not dissolve or detrimentallyalter the foam. One preferred embodiment can include water as theextraction solvent, for example distilled-deionized water. Such aprocess is described further in U.S. Pat. No. 5,514,378, the contents ofwhich is incorporated by reference herein in its entirety. Preferablythe foam will be dried after the leaching process is complete at lowtemperature and/or vacuum to minimize hydrolysis of the foam unlessaccelerated absorption of the foam is desired.

Non-bioabsorbable materials can include, for example, bioinert ceramicparticles (e.g., alumina, zirconia, and calcium sulfate particles),polymers such as polyethylene, polyvinylacetate, polymethylmethacrylate,polypropylene, poly(ethylene terephthalate), silicone, polyethyleneoxide, polyethylene glycol, polyurethanes, polyvinyl alcohol, naturalpolymers (e.g., cellulose particles, chitin, and keratin), andfluorinated polymers and copolymers (e.g., fluoride,polytetrafluoroethylene, and hexafluoropropylene). In one embodiment, itis possible to add solids (e.g., barium sulfate) that will render thetissue implants radio opaque. Those solids that may be added alsoinclude those that will promote tissue regeneration or healing, as wellas those that act as buffers, reinforcing materials or porositymodifiers.

As discussed above, polymeric foam components can contain a reinforcingcomponent. The construct can be made by injecting, pouring, or otherwiseplacing, the appropriate polymer solution into a mold set-up comprisedof a mold and the reinforcing elements of the present disclosure. Themold set-up can be cooled in an appropriate bath or on a refrigeratedshelf and then lyophilized, thereby providing a reinforced construct.

In embodiments that utilize a polymeric foam, one or more of thebiological components provided for throughout the present disclosure canbe added either before or after the lyophilization step. In the courseof forming the polymer foam component, it can be beneficial to controlthe rate of freezing of the polymer-solvent system. The type of poremorphology that is developed during the freezing step is a function offactors such as the solution thermodynamics, freezing rate, temperatureto which it is cooled, concentration of the solution, and whetherhomogeneous or heterogeneous nucleation occurs. The orientation of thepolymeric fibers can be regulated be controlling the pore orientation.The pores orientation in the polymeric form component can be customized,for example, by controlling the temperature gradient induced during thefreezing cycle. Controlling the orientation of fibers can result in animprovement in the mechanical properties in the direction that thefibers are oriented.

The required general processing steps for a construct that usespolymeric foam can include the selection of the appropriate materialsfrom which the polymeric foam will be made. The processing steps canadditionally include selection of the materials of the reinforcingcomponents if used. If a mesh reinforcing material is used, the propermesh density should be selected. Further, the reinforcing materialshould be properly aligned in the mold, the polymer solution should beadded at an appropriate rate and, preferably, into a mold that is tiltedat an appropriate angle to avoid the formation of air bubbles, and thepolymer solution must be lyophilized.

In embodiments that utilize a mesh reinforcing material in a polymericfoam, for example, the reinforcing mesh should be selected to be of acertain density. That is, the openings in the mesh material should notbe so small so as to impede proper bonding between the foam and thereinforcing mesh as the foam material and the open cells and cell wallsthereof penetrate the mesh openings. Without proper bonding theintegrity of the layered structure can be compromised, leaving theconstruct fragile and difficult to handle. The density of the mesh candetermine the mechanical strength of the construct. The density of themesh can vary according to the desired use for tissue repair. Inaddition, the type of weave used in the mesh can determine thedirectionality of the mechanical strength of the construct, as well asthe mechanical properties of the reinforcing material, such as forexample, the elasticity, stiffness, burst strength, suture retentionstrength, and ultimate tensile strength of the construct. By way ofnon-limiting example, the mesh reinforcing material in a foam-basedbiocompatible construct of the present disclosure can be designed to bestiff in one direction, yet elastic in another, or alternatively, themesh reinforcing material can be made isotropic.

During lyophilization of the reinforced foam in those embodiments thatutilize a mesh reinforcing material in a polymeric foam, severalparameters and procedures can be helpful to produce implants with thedesired integrity and mechanical properties. For example, ifreinforcement material is used, it can be beneficial to maintain thereinforcement material substantially flat when placed in the mold. Toensure the proper degree of flatness, the reinforcement (e.g., mesh) canbe pressed flat using a heated press prior to its placement within themold. Further, in the event that reinforcing structures are notisotropic, it can be desirable to indicate this anisotropy by markingthe construct to indicate directionality. The marking can beaccomplished by embedding one or more indicators, such as dyed markingsor dyed threads, within the woven reinforcements. The direction ororientation of the indicator can, for example, indicate to a surgeon thedimension of the implant in which physical properties are superior.

In embodiments that utilize polymeric foam, as noted above, the mannerin which the polymer solution is added to the mold prior tolyophilization can help contribute to the creation of a tissue implantwith adequate mechanical integrity. Assuming that a mesh reinforcingmaterial will be used, and that it will be positioned between two thin(e.g., approximately 0.75 millimeters) shims, the mesh can be positionedin a substantially flat orientation at a desired depth in the mold. Thepolymer solution can be poured in a way that allows air bubbles toescape from between the layers of the foam component. The mold can betilted at a desired angle and pouring is effected at a controlled rateto best prevent bubble formation. A number of variables will control thetilt angle and pour rate. For example, the mold should be tilted at anangle of greater than about one degree to avoid bubble formation. Inaddition, the rate of pouring should be slow enough to enable any airbubbles to escape from the mold, rather than to be trapped in the mold.

In those embodiments that utilize a mesh reinforcing material in apolymeric foam, the density of the mesh openings can be an importantfactor in the formation of the construct with the desired mechanicalproperties. For example, a low density, or open knitted mesh material,can be used. One example of such a material is a 90:10 copolymer ofglycolide and lactide, sold under the tradename VICRYL, which isavailable from Ethicon, Inc. of Somerville, N.J. One exemplary lowdensity, open knitted mesh is Knitted VICRYL VKM-M, which is alsoavailable from Ethicon, Inc. of Somerville, N.J. Other materials caninclude but are not limited to polydioxanone and a 95:5 copolymer blendof lactide and glycolide.

In embodiments that utilize a polymeric foam, a through opening can becreated by placing a rod in the polymeric foam solution/slurry before ithas set. After the polymeric form is formed, the rod can be removed. Forexample, if the polymeric foam is made by lyophilization, the rod isremoved after the freeze and vacuum drying cycle. The rod can have anydesired shape.

The polymeric foam component can, optionally, contain one or more layersmade of the materials discussed above. In one embodiment, the foamcomponent can be integrated with the material(s) by creating pores inthe materials and then the polymeric foam component penetrate the porescreated in the materials(s) and interlock with the material(s). Inanother embodiment, pores are formed in materials of two layers, and thetwo layers are put together to best align the pores. The two layercombination can be placed in a polymeric solution or slurry, and thepolymeric foam can be formed by one of the methods provided for hereinor otherwise known to those skilled in the art.

In some embodiments, a construct can be formed from an expanding mediathat can advantageously provide added compression at the repair site.One non-limiting example of such a construct 2910 is shown in FIG. 29A,in which the construct is a patch or scaffold (as described in greaterdetail below). For example, the construct 2910 can be formed from awoven or braided mesh having a core 2904 surrounded or sandwichedbetween two layers 2902 a, 2902 b. The two layers 2902 a, 2902 b can bereferred to as a jacket. The core 2904 can be made from a variety ofmaterials that are capable of expanding, such as silicone loaded withsalt, sodium polyacrylate, polyacrylamide copolymer, polyurethanes, andother absorbent polymers and hydro gels, while the jacket 2902 a, 2902 bcan be more rigid so that the core can compress against the jacket as itexpands in use. Non-limiting exemplary materials that can be used toform the jacket 2902 a, 2909 b include fabric and filament such aspolyethylene, polypropylene, polyester, poly(ethylene terephthalate),nylon, polyurethanes and silk. Further non-limiting exemplary materialsthat can be used to form the jacket 2902 a, 2902 b include bioabsorbablematerials such as polylactic acid (PLA), polyglycolic acid (PGA),polycaprolactone (PCL), polydioxanone (PDO), trimethylene carbonate(TMC), copolymers or blends thereof. Some materials that can be used inconjunction with the construct include, but are not limited to, thosedisclosed and provided for in U.S. Pat. No. 8,870,915, entitled “JoiningElement,” the contents of which is incorporated by reference herein inits entirety. The construct 2910 can have a length L_(P) and a thicknessT_(P), as shown in FIG. 29A, and can include at least one suture limb2911 for affixing the construct to one or more repair sites. In theillustrated example the construct 2910 includes four suture limbs 2911,2912, 2913, 2914 associated with it. The limbs can be from the same ordifferent sutures.

In use, as shown in FIG. 29B, the construct 2910 can be placed over therepair sites 2938 a, 2938 b, and the suture limbs 2911, 2912, 2913, 2914can be fixed within respective anchors 2961, 2962, 2963, 2964. As withother disclosures, the repairs associated with the repair sites 2938 a,2938 b can be any type of repair provided for herein or otherwise knownto those skilled in the art. The construct 2910 can be further affixedto a location medial of the repairs 2938 a, 2938 b with sutures,staples, or other devices and components used to fixate tissue withrespect to bone. As shown, sutures 2940 a-2940 c provide the fixation.The construct 2910 can be exposed to an aqueous solution, for exampleafter installation, such that the silicone and salt filled core canabsorb the fluid to cause the construct to expand in at least onedimension and contract in at least one other dimension based on theconfiguration of the construct 2910. In the illustrated example, theexpansion causes the construct 2910 to increase in thickness T_(P) whilecontracting and decreasing across its length L_(P). The decrease in thelength L_(P) after the construct 2910 is installed can increase thecompressive forces to the soft tissue 2930 to bring the tissue into moreuniform contact with the bone 2950 due, at least in part, to the limitedspace for fixation of the construct 2910, the configuration of theconstruct 2910, and the surface geometry of the attachment site. Oneskilled in the art will appreciate that a configuration of a constructhaving a core, capable of expanding, sandwiched between layers or ajacket can be used with other construct configurations provided forherein, including those that are not necessarily a patch or scaffold, toprovide for added compressive forces at repair sites. A furtherdiscussion of tissue augmentation patches and scaffolds is providedbelow.

Unless specified otherwise, any of the materials, and any of thetechniques disclosed for forming materials, can be used in conjunctionwith any of constructs provided for herein. This includes anycombination of materials. Likewise, the manufacturing techniquesdisclosed can generally be used, or adapted to form the variousconstructs provided for herein. The use of materials and manufacturingtechniques for various tissue augmentation constructs is within thespirit of the present disclosure.

Tissue Augmentation Constructs—Tissue Augmentation Patches

Tissue augmentation constructs can also come in form of a patch orscaffold that can be associated with one or more limbs of suture toincrease a footprint of the one or more limbs and to provide additionalsurface area across which forces to be distributed, among other benefitsarticulated throughout the present disclosure, e.g., enhancing healingof otherwise compromised tissue and/or providing bulk to otherwisecompromised or degenerate tissue and/or tendon. The patches can bedisposed on, or even attached or coupled, to the suture rather than justsitting on top of operative sutures. Further, the instant patches can bedelivered to the surgical site and threaded onto sutures using a suturethreader as described herein, thereby obviating the need for extensivesuturing of each edge of a patch. A number of different techniques canbe used to associate the illustrated patches with suture, includingthreading the suture through the patch and/or disposing the suture inbetween layers of a scaffold. The patch can then be disposed proximateto a surgical site as described. Methods of manufacturing a scaffold orpatch, and methods of installing various scaffolds and patches, are alsoprovided for below. The systems and methods disclosed herein allow forquick, easy, and affordable techniques for preventing damage to tissueby tensioned suture. Like the other constructs described above, asurgeon can apply the patch(es) in an on-demand manner to create desiredsuture footprints for the repair. A person skilled in the art willrecognize that the disclosures provided for herein related to tissueaugmentation blocks, e.g., by way of non-limiting example, the materialsused to form the tissue augmentation blocks 10, 110, 3010, 3110, 310,410, among other constructs, can be applied to the patches discussedbelow.

One exemplary embodiment of a tissue augmentation construct 2210 havinga patch or scaffold configuration is provided for in FIGS. 30A and 30B.As shown, the tissue augmentation patch 2210 has a rectangular-shapedbody and can be disposed on or otherwise associated with suture limbs2212 a, 2212 b. In the illustrated embodiment the patch 2210 includesbores or lumens 2214 a, 2214 b are formed in the body and extendtherethrough from a proximal-most end 2210 p to a distal-most end 2210d. The bores 2214 a, 2214 b can be used, for example, to receive thesuture limbs 2212 a, 2212 b so that the patch 2210 and limbs 2212 a,2212 b can be associated with each other. As shown in FIG. 30B, thepatch 2210 can be pre-threaded with suture threaders 2206 a, 2206 b. Thethreaders 2206 a, 2206 b are of a similar nature as the threader 206′,and can also be configured in a manner akin to the threader 206 or inmanners otherwise known to those skilled in the art and/or derivablefrom the present disclosures. As shown, the patch 2210 has a lengthL_(P) that is substantially equal to a width W_(P), and it also has athickness T_(P). Further, the thickness T_(P) can be greater than adiameter of a filament or suture with which the tissue augmentationpatch 2210 is associated, e.g., the suture limb 2212 a.

A person skilled in the art will recognize that the dimensions of thelength L_(P), the width W_(P), and the thickness T_(P) of the tissueaugmentation patch 2210, as well as a diameter of the bores 2214 a, 2214b, can depend on a variety of factors, including but not limited to thesize of the filament with which it is to be associated, the anatomy ofthe patient, and the type of procedure being performed. Some exemplary,non-limiting dimensions for a tissue augmentation patch 2210 can beuseful in understanding the present disclosure.

In some embodiments, the length L_(P) can cover a significant portion,to almost an entire portion, of a length of tissue extending between astitch made in tissue and a bone anchor used to help secure the tissue.In some embodiments, the length L_(P) and width W_(P) can beapproximately in the range of about 10 millimeters to about 50millimeters, and the thickness T_(P) can be approximately in the rangeof about 0.5 millimeters to about 5 millimeters. The size of thediameter of the bores 2214 a, 2214 b can also depend on a variety offactors, including but not limited to the size of the limb to be passedtherethrough. In some embodiments, the diameter can be approximately inthe range of about 0.5 millimeters to about 3 millimeters.

A number of techniques known to those skilled in the art can be used toassociate the patch 2210 with the suture limbs 2212 a, 2212 b. Suturelimbs 2212 a, 2212 b can be threaded or passed from the proximal-mostend 2210 p to the distal-most end 2210 d of the patch 2210 withoutpassing across the body of the patch 2210, i.e., without passing throughsidewalls that define the bores 2214 a, 2214 b. As a result, the patch2210 can freely pass along a length of the limbs 2212 a, 2212 bunhindered or unrestricted. In other embodiments, the limbs 2212 a, 2212b can pass across the body once or more, e.g., like the embodiment ofthe strip or tape 10 illustrated in FIG. 1B, to further secure alocation of the patch 2210 with respect to the limbs 2212 a, 2212 b. Instill other embodiments, the limbs 2212 a, 2212 b can be passed throughthe patch 2210 from the proximal-most end 2210 p to the distal-most end2210 d by passing through the body while only entering and exiting thebody one time, for instance when no bores 2214 a, 2214 b are provided.Of course, the limbs 2212 a, 2212 b do not necessarily have to extendall the way to the proximal-most or distal-most ends 2210 p, 2210 d, butinstead can enter and or exit the patch 2210 at some other locationacross its surface area. A person skilled in the art will recognize avariety of other ways by which the patch 2210 can be associated with thelimbs 2212 a, 2212 b without departing from the spirit of the presentdisclosure.

The tissue augmentation patch 2210 can be threaded by hand on to thesuture limbs 2212 a, 2212 b, either at the surgical site, or outside ofthe body. Alternatively, as shown in FIG. 30B, the threaders 2206 a,2206 b can be operated to associated the suture limbs 2212 a, 2212 bwith the patch 2210, with the operation being akin to either thethreader 206 or the threader 206′ described above, and thus includingproximal handle portions 2208 a, 2208 b, intermediate elongate portions2207 a, 2207 b, and distal suture-receiving ends 2209 a, 2209 b.Accordingly, the tissue augmentation patch 2210 can be associated withthe intermediate elongate portions 2207 a, 2207 b, as shown by passingthe intermediate elongate portions 2207 a, 2207 b through the lumens2214 a, 2214 b, and the limbs 2212 a, 2212 b can be coupled to thedistal suture-receiving ends 2209 a, 2209 b. The proximal handleportions 2208 a, 2208 b can be grasped and pulled away from the tissueaugmentation patch 2210 to advance the limbs 2212 a, 2212 b towards andinto the patch 2210. After the patch 2210 has been successfullyassociated with the limbs 2212 a, 2212 b, the threaders 2206 a, 2206 bcan be disassociated with the limbs 2212 a, 2212 b and the tissueaugmentation patch 2210 and can be either discarded or re-used.

Similar to the earlier described tissue augmentation strips, associatingthe tissue augmentation patch 2210 with the suture limbs 2212 a, 2212 bincreases the footprint of the suture limbs 2212 a, 2212 b and may allowforce applied to the tissue by the suture limbs 2212 a, 2212 b to bedistributed over a larger amount of surface area, i.e., the surface areaof the patch 2210. The increased distributed force of the tissueaugmentation patch 2210 may result in a reduced pressure peak on thesoft tissue. Where the soft tissue has become degenerated due to injuryor age, an increased tissue surface area coverage and a reduction inpressure can result in less chance of abrasion of the tissue. Further,the larger surface area of the tissue augmentation patch 2210 canprovide for a larger scaffold for new tissue to generate over the repairto further strengthen the repair site. The broader tissue coverageprovided by the patch 2210 may enhance the healing of otherwisecompromised tissue and/or provide bulk to otherwise compromised ordegenerate tissue and/or tendon.

Methods of Manufacturing Tissue Augmentation Constructs—TissueAugmentation Patches

The tissue augmentation patch 2210 can be manufactured using a number ofdifferent techniques, some of which have been previously discussed abovewith regards to the tissue augmentation blocks 10, 110. In one exemplaryembodiment of making a tissue augmentation patch, illustrated by FIGS.30C-30E, the material being used to make the patch 2210 can be harvestedor otherwise acquired using techniques known to those skilled in theart. The material can then be shaped using any of the techniquesdescribed above, for instance those described with respect to the strip10, or otherwise known to those skilled in the art in view of thepresent disclosures. A piece of material can be harvested having alength L_(P), a width 2W_(P), and a thickness ½ T_(P). The width 2W_(P)can be double the resulting width W_(P) of the patch 2210 and thethickness ½ T_(P) can be half of the thickness of the resulting patch2210. As shown in FIG. 30D, the piece of material 2220 can have a firstend 2220 a and a second end 2220 b with the width 2W_(P) extendingtherebetween. Alternatively, the piece of material 2220 can have anyshape.

Once the piece of material 2220 has been cut out, two pins 2222 a, 2222b can be placed onto the same side of the material, approximately ¼ ofthe width 2W_(P) away from the first and second ends 2220 a, 2220 b,respectively. The two ends 2220 a, 2220 b, can be folded over therespective pins 2222 a, 2222 b, and brought proximate to one another andsubsequently attached to one another, thereby forming the patch 2210. Asshown in FIGS. 30C and 30D, the four rows of stitches 2224 a-2224 d canbe stitched into the folded patch such that they are substantiallyparallel to one another. Further, the first and the fourth stitches 2224a, 2224 d can be located substantially parallel to and proximate thepins 2222 a, 2222 b, respectively. Still further, the stitches 2224 a,2224 d can create the two lumens 2214 a, 2214 b that are held open bythe pins 2222 a, 2222 b. After the stitching is complete, the pins 2222a, 2222 b can be removed, leaving the patch 2210 as shown in FIG. 30E.Alternatively, no pins are required to manufacture the patch 2210. Thesecond and the third stitches 2224 b, 2224 c can be locatedsubstantially parallel to and proximate the two ends 2220 a, 2220 b.Further alternatively, in place of stitches, the material 2220 can besecured to itself with the use of glue, collagen bond, staples, lightcuring, or other techniques known to those skilled in the art forattaching soft tissue to soft tissue and provided for throughout thepresent disclosure. In embodiments that include threaders predisposed inthe patch 2210, threaders 2206 a, 2206 b can be inserted into the lumens2214 a, 2214 b before the two ends 2220 a, 2220 b are attached, orafter. Like the other constructs provided for herein, the patch 2220 canbe dried for packaging at any suitable point during the manufacturingprocess.

An alternative method of manufacturing the patch 2210 can includeharvesting a piece of material that can be harvested having a lengthL_(P), a width W_(P), and a thickness T_(P). The piece of material 2220can have a first end 2220 a and a second end 2220 b with the width W_(P)extending therebetween. A first pin 2222 a can be inserted, or pierced,into the material 2220 proximate and parallel to the first end 2220 a tocreate a first lumen 2214 a. A second pin 2222 b can be inserted, orpierced, into the material 2220 proximate and parallel to the second end2220 b to create a second lumen 2214 b. In a further alternative, acoring tube can be used in place of the pins 2222 a, 2222 b, asdescribed above with respect to FIGS. 26A-26I. The patch 2210 can bemade from any of the materials provided for above with respect to theblocks 10, 110, 3010, 3110, 310, and 410, and any other constructs,noted above. Furthermore, the patch 2210 can have any shape, includingrectangular, trapezoidal, ovoid, circular, square, pentagonal,hexagonal, octagonal, etc.

A further alternative method of manufacturing a patch 3320 can includethe use of a parallel production tunneling station 3300, similar to thetunneling stations 3200, 3200′ of FIGS. 27A-27M. As shown in FIG. 31A, astage 3320 can accommodate a larger length L of the material 3330. Forexample, as illustrated in FIG. 31A, the stage 3320 can accommodate twopatch constructs 3310 a, 3310 b. Alternatively, the stage 3320 canextend to accommodate any number of constructs. The stage 3320 can,similar to the stage of the tunneling station 3200′, have a plurality ofsemi-circular reliefs that can be aligned with lumen formation tools3324 a, 3324 b, 3324 c, 3324 d, and the stage 3320 can beself-centering.

Similar to the tunneling stations 3200, 3200′ of FIGS. 27A-27M, thetunneling station 3300 can include a plurality of lumen formation tools3324 a, 3324 b, 3324 c, 3324 d. In the illustrated embodiment, the lumenformation tools 3324 a, 3324 b forms a first station 3323 a, and thelumen formation tools 3324 c, 3324 d forms a second station 3323 b. Asshown, the lumen formation tools 3324 a, 3324 b can be angularly offsetfrom one another, for example approximately up to about 30 degrees fromone another. In one embodiment, the lumen formation tools 3324 a, 3324 bcan be angularly offset from one another approximately 16 degrees fromone another. The lumen formation tools 3324 c, 3324 d of the secondstation 3323 b can be similarly offset relative to one another, oralternatively, can be angularly offset at a different angle. The secondstation 3323 b can be disposed on an opposite side of the stage 3320from the first station 3323 a, thus providing for easier parallel lumenformation. In an alternative embodiment, each of the lumen forming tools3324 a, 3324 b, 3324 c, 3324 d can be aligned in parallel with eachother. The lumen formation tools 3324 a, 3324 b, 3324 c, 3324 d can bealigned such that each of the respective cutting tools 3322 a, 3322 b,3322 c, 3322 d can translate towards the stage to create the lumens 3314a, 3314 b, 3314 c, 3314 d in the material 3330. In the illustratedembodiment, two lumen formation stations 3323 a, 3323 b are shown,however any number of lumen forming stations can be provided.

After each of the lumen formation tools 3324 a, 3324 b, 3324 c, 3324 dhas been actuated and retracted to create lumens 3314 a, 3314 b, 3314 c,3314 d in the material 3330, the material 3330 can be advanced in thedirection D as shown in FIG. 31A. The individual constructs 3310 a, 3310b, 3310 c can then be separated by means of a punch 3190 a-3190 c, orother cutting mechanisms as provided for throughout the presentdisclosure or otherwise known to those skilled in the art. The resultingconstructs 3310 a, 3310 b, 3310 c, 3310 d are illustrated in FIGS. 31Band 31C, with the resulting patches 3310 a, 3310 b, 3310 c, 3310 dhaving a generally trapezoidal shape. A person skilled in the art willrecognize that any number of patch shapes can be formed in view of thepresent disclosures. For example, the lumen formation tools 3324 a, 3324b, 3324 c, 3324 d can be parallel to each other to create patches havingparallel lumens and a rectangular shape.

Methods of Use—Tissue Augmentation Patches

One exemplary method of installing a tissue augmentation patch 2210 isillustrated in FIG. 30F. The illustrated method provides for a piece ofsoft tissue 2230, e.g., rotator cuff, fixated to bone 2250. Either asingle row or a double row repair can be used. Once the surgeon hasaccess to the surgical site and the tissue, bone, and tissueaugmentation patch have been prepared according to accepted surgicaltechniques including those provided for herein, the surgeon can performa tissue repair (not visible because it is underneath the patch 2210)according to accepted surgical techniques. As shown in FIG. 30F, asuture 2212 extending from an anchor (not shown) used in the repair isinstalled into the tissue 2230 medially from the repair such that twosuture limbs 2212 a, 2212 b extend out from the tissue 2230.

The tissue augmentation patch 2210 can be threaded onto the suture limbs2212 a, 2212 b using techniques provided for throughout the presentdisclosure, and subsequently advanced along the respective suture limbs2212 a, 2212 b until it is proximate a medial stitch 2242. After thetissue augmentation patch 2210 has been installed on the suture limbs2212 a, 2212 b, the free end of each suture limb 2212 a, 2212 b can besecured within the body. For example, the free ends of each suture limb2212 a, 2212 b can be coupled to respective anchors 2260 a, 2260 b in alateral row fixation. The suture limbs 2212 a, 2212 b can then betightened to secure the patch 2210 against the repair before the anchors2260 a, 2260 b are fully fixed in the bone 2250.

The tissue augmentation patch 2210 can provide a greater footprint forthe suture limbs 2212 a, 2212 b and a greater surface area to distributethe loading forces of the suture limbs 2212 a, 2212 b onto the softtissue 2230. While the patient is healing from the procedure, the patchcan remodel into tendon-like tissue and integrate with the underlyingnative tissue. The additional coverage of tendon-like tissue across thesoft tissue can increase the strength of the soft tissue to boneconnection and may prevent further injury.

Another exemplary method of installing a tissue augmentation patch 2210′is provided for in FIGS. 30G-30I, this time illustrating a piece of softtissue 2230′, e.g., rotator cuff, being fixated to bone 2250′ using adouble row repair. Once the surgeon has access to the surgical site andthe tissue, bone, and tissue augmentation patch have been preparedaccording to accepted surgical techniques including those provided forherein, the surgeon can install first and second medial anchors 2260 a′,2260 b′ in the bone 2250′. The first and second medial anchors 2260 a′,2260 b′ have sutures 2212′, 2216′ associated therewith. As shown in FIG.30G, sutures 2212′ and 2216′ can have suture limbs 2212 a′, 2212 b′ and2216 a′, 2216 b′ extending from the respective anchors 2260 a′ and 2260b′, with the limbs being threaded through the tissue 2230′, for exampleusing one or more medial stitches 2242 a′, 2242 b′.

The patch 2210′ can have similar properties as the patch 2210 and can bethreaded onto the suture limbs 2212 a′, 2216 a′ using techniquesprovided for throughout the present disclosure. The patch 2210′ cansubsequently be advanced in the direction D₁ along the respective suturelimbs 2212 a′, 2216 a′, as shown in FIG. 30H, until it is proximate themedial stitches 2242 a′, 2242 b′. After the patch 2210′ has beeninstalled on the suture limbs 2212 a′, 2216 a′, the free end of each ofthe suture limbs 2212 b′, 2216 b′ can be placed over the patch 2210′ inan X− or crossed configuration as shown in FIG. 30I. Then the suturelimbs 2212 a′, 2216 b′ can be installed into lateral anchor 2262 a′, andthe suture limbs 2212 b′, 2216 a′ can be installed into lateral anchor2262 b′ in a lateral row fixation. The suture limbs 2212 a′, 2212 b′,2216 a′, 2216 b′ can then be tightened to secure the soft tissue 2230′to the bone 2250′ before the lateral anchors 2262 a′, 2262 b′ are fullyfixed in the bone 2250′. The same benefits described above with respectto the method of using the patch 2210 are equally applicable to thisembodiment of using the patch 2210′. Further, the crossed nature of thesuture configuration provides additional stability for holding thetissue 2230′ at the desired location with respect to the bone 2250′.

A further exemplary embodiment of installing a tissue augmentation patch2210″ is illustrated in FIGS. 30J-L and can be used with either a singleor double row repair described above with regards to FIGS. 30F-I. Theillustrated patch 2210″ has been threaded onto suture limbs 2212 a″,2216 a″ according to techniques provided for throughout the presentdisclosure. The illustrated method provides for forming collapsibleloops 2212 l″, 2216 l″ and associated knots 2270 a″, 2270 b″ disposed ona distal end 2210 d″ of the patch 2210″. The collapsible loops 2212 l″,2216 l″ and associated knots 2270 a″, 2270 b″ can be formed onrespective suture limbs 2212 a″, 2216 a″ after the suture limbs havebeen threaded through the patch 2210″. In one exemplary embodiment theknots can be, for example, sliding knots, figure eight knots, or fingertraps, among other knot types. The knots 2270 a″, 2270 b″ can be largerthan the associated lumens through which the suture limbs 2212 a″, 2212b″ are threaded through such that the knots 2270 a″, 2270 b″ cannot bepulled through. The knots 2270 a″, 2270 b″ can be formed after the patch2210″ has been advanced in the direction D1 until it is proximate thesoft tissue 2230″.

After the loops 2212 l″, 2216 l″ have been formed, the suture limb 2216b″ can be guided through the loop 2212 l″ and the suture limb 2212 b″can be guided through the loop 2216 l″, as illustrated in FIG. 30K. Oncethe suture limbs 2212 b″, 2216 b″ have been threaded through the sutureloops 2212 l″, 2216 l″, the suture limbs are beneficially maintained ina desired configuration. The suture limbs 2212 a″, 2216 b″ can then beinstalled into a lateral anchor 2262 a″, and the suture limbs 2212 b″,2216 a″ can be installed into a lateral anchor 2262 b″ in a lateral rowfixation. At this point, the collapsible loops 2212 l″, 2216 l″ can becollapsed by the application of a force on suture limbs 2212 a″, 2216a″, thereby securing suture limbs 2212 b″, 2216 b″ in an X− or crossedconfiguration as shown in FIGS. 30K and 30L. The suture limbs 2212 a″,2212 b″, 2216 a″, 2216 b″ can then be tightened to secure the softtissue 2230″ to the bone 2250″ before the lateral anchors 2262 a″, 2262b″ are fully fixed in the bone 2250″. One benefit of the knots 2270 a″,2270 b″ and loops 2212 l″, 2216 l″ is that the patch 2210″ can beprevented from sliding laterally towards anchors 2262 a″, 2262 b″ andfixed relative to the bone 2250″ and 2230″. By collapsing the loops 2212l″, 2216 l″ around the sutures limbs 2212 a″, 2212 b″, 2216 a″, 2216 b″,unintentional sliding of the patch 2210″ with respect to the sutureslimbs 2212 a″, 2212 b″, 2216 a″, 2216 b″ can be prevented. The loops andknots can be beneficially applied to any of the constructs provided forherein to prevent lateral sliding and to retain the construct afterimplantation, including but not limited to tissue augmentation blocksand tissue augmentation patches.

Tissue Augmentation Constructs—Additional Tissue Augmentation Patches,Methods of Using the Same, and Methods of Manufacturing the Same

Another exemplary embodiment of a tissue augmentation construct 2310having a patch or scaffold configuration is illustrated in FIG. 32A. Asshown, the tissue augmentation patch 2310 has a rectangular-shaped bodyand is generally similar in nature and construction to the tissueaugmentation patch 2210. The patch 2310 differs in that it includesadditional lumens 2314 a-2314 d extending therethrough from aproximal-most end 2310 p to a distal-most end 2310 d for havingthreaders 2306 a-2306 d, and thus suture limbs 2312 a, 2312 b, 2316 a,2316 b after operating the threaders 2306 a-2306 d, disposed therein.Optionally the threaders 2306 a-2306 d may not be used and the suturelimbs 2312 a, 2312 b, 2316 a, 2316 b may be associated with the patch2310 using any technique provided for herein or otherwise known to thoseskilled in the art. As shown in FIG. 32A, the lumens 2314 a, 2314 d canbe substantially parallel to the sides of the patch 2310 that extendbetween the proximal-most end surface 2310 p and the distal-most endsurface 2310 d, and the lumens 2314 b, 2314 c can form a substantiallyX-shaped or crossed configuration. When the threaders 2306 a and 2306 bare associated with the patch 2310 in the illustrated embodiment, or inother embodiments illustrated herein having a patch with two threadersassociated therewith, an intermediate portion 2307 a of the firstthreader 2306 a can be disposed at a location that is more proximate toa first side 2310 a of the patch 2310 than a second, opposite side 2310b of the patch and an intermediate portion 2307 b of the second threader2306 b can be disposed at a location that is more proximate to thesecond side 2310 b than the first side 2310 a. When the threaders 2306 cand 2306 d are also associated with the patch 2310, an intermediateportion 2307 c of the third threader can be disposed diagonally withrespect to the patch 2310 such that a distal receiving end 2309 c of thethird threader 2306 c is proximate to a distal receiving end 2309 a ofthe first threader 2306 a, while a proximal handle 2308 c of the thirdthreader 2306 c is proximate to a proximal handle 2308 b of the secondthreader 2306 b, and an intermediate portion 2307 d of the fourththreader can be disposed diagonally with respect to the patch 2310 suchthat a distal receiving end 2309 d of the fourth threader 2306 d isproximate to a distal receiving end 2309 b of the second threader 2306b, while a proximal handle 2308 d of the fourth threader 2306 d isproximate to a proximal handle 2308 a of the first threader 2306 a.

A person skilled in the art will recognize that in any embodiments inwhich multiple threaders are used in conjunction with a construct, alocation of the proximal and distal ends of the threaders can bedifferent than the illustrated embodiments, depending, at least in part,on the type of procedure being performed, the components being used toperform the procedure, and the preferences of the user. Thus, in anyillustrated embodiments, locations of the proximal and distal ends ofthe threaders can be switched in other embodiments. Further, in any ofthe illustrated embodiments, a location of any threader with respect toa tissue augmentation construct prior to using the threaders toassociate a suture with the tissue augmentation construct is considereda pre-installation configuration, and after a threader has been used toassociate a suture with a tissue augmentation construct and subsequentlyremoved, such a configuration is considered a post-installationconfiguration.

As shown, the patch 2310 has a length L_(P)′ that is substantially equalto a width W_(P)′, and it also has a thickness T_(P)′. Further, thethickness T_(P)′ can be greater than a diameter of a filament or suturewith which the tissue augmentation patch 2310 is associated, e.g., thesuture limb 2312 a. In other embodiments, the suture limbs 2312 a, 2312b, 2316 a, 2316 b can extend through the lumens 2314 a-2314 d withoutnecessarily having been disposed in the lumens 2314 a-2314 d usingthreaders. The limbs 2312 a, 2312 b, 2316 a, 2316 b can extend in thesame hybrid parallel and crossed configuration illustrated and describedwith respect to the locations of the threaders 2306 a-2306 d.

A person skilled in the art will recognize that the dimensions of thelength L_(P)′, the width W_(P)′, and the thickness T_(P)′ of the tissueaugmentation patch 2310, as well as a diameter of the bores 2314 a-2314d, can depend on a variety of factors, including but not limited to thesize of the filament with which it is to be associated, the anatomy ofthe patient, and the type of procedure being performed. Alternatively,the patch 2310 can have any other shape (e.g., rectangular, trapezoidal,ovoid, circular, square, pentagonal, hexagonal, octagonal, etc.) and thelumens 2314 a-2314 d can follow any path (e.g., they can follow edges).The exemplary, non-limiting dimensions provided above for the patch 2210can also be applicable to the size of the patch 2310, with theunderstanding that other dimensions are possible. Likewise, a number oftechniques known to those skilled in the art can be used to associatethe patch 2310 with the suture limbs 2312 a, 2312 b, 2316 a, 2316 b, andthe techniques described above with respect to the patch 2210 can beadapted for use in conjunction with the patch 2310. Thus, in view of thepresent disclosures, a person having skill in the art will understandhow to operate the threaders 2306 a-2306 d to associate the suture limbs2312 a, 2312 b, 2316 a, 2316 b with the patch 2310.

One exemplary method of installing the patch 2310 is provided for inFIGS. 32B-32E. The illustrated method provides for a piece of softtissue 2330, e.g., rotator cuff, fixated to bone 2350. Either a singlerow or a double repair can be used. Once the surgeon has access to thesurgical site and the tissue, bone, and tissue augmentation patch havebeen prepared according to accepted surgical techniques including thoseprovided for herein, the surgeon can perform single row repairs 2340 a,2340 b of the tissue 2330 according to accepted surgical techniques.Alternatively, one repair can be made to the tissue 2330, or more thantwo repairs can be completed. As shown in FIG. 32C, a first suture 2312can be inserted into the tissue 2330 medially from the repairs 2340 a,2340 b such that two suture limbs 2312 a, 2312 b extend out from thetissue 2230, and likewise, a second suture 2316 can be inserted into thetissue 2330 medially from the repairs 2340 a, 2340 b such that twosuture limbs 2316 a, 2316 b extend out from the tissue 2230. In theillustrated embodiment, the sutures 2312, 2316 are inserted into thetissue 2330 using mattress stitches 2342 a, 2342 b, respectively, thoughother stitches can be used.

As shown in FIG. 32D, the suture limbs 2312 a, 2312 b, 2316 a, 2316 bare threaded into lumens 2314 a-2314 d, respectively, using techniquesprovided for throughout the present disclosure, e.g., operating thethreaders 2306 a-2306 d, and the patch 2310 can be advanced along therespective suture limbs 2312 a, 2312 b, 2316 a, 2316 b until theproximal end 2310 p is proximate the medial stitches 2342 a, 2342 b.After the patch 2310 has been installed on the suture limbs 2312 a, 2312b, 2316 a, 2316 b, the free end of each suture limb 2312 a, 2316 b canbe secured within the body. For example, as shown in FIG. 32E, the freeends of each suture limb 2312 a, 2316 b and 2312 b, 2316 a can becoupled to lateral anchor 2362 a and 2362 b, respectively, in a lateralrow fixation. The suture limbs 2312 a, 2312 b, 2316 a, 2316 b can thenbe tightened to secure the patch 2310 against the repair 2340 before thelateral anchors 2360 a, 2360 b are fully fixed in the bone 2350.

Another exemplary method of installing a tissue augmentation patch 2310′is provided for in FIGS. 32F-32H, this time illustrating a piece of softtissue 2330′, e.g., rotator cuff, being fixated to bone 2350′ using adouble row repair. Once the surgeon has access to the surgical site andthe tissue, bone, and patch have been prepared according to acceptedsurgical techniques including those provided for herein, the surgeon caninstall first and second medial anchors 2360 a′, 2360 b′ in the bone2350′. The first and second medial anchors 2360 a′, 2360 b′ have sutures2312′, 2316′ associated therewith. As shown in FIG. 32F, sutures 2312′and 2316′ can have suture limbs 2312 a′, 2312 b′ and 2316 a′, 2316 b′extending from the respective anchors 2360 a′ and 2360 b′, with thelimbs being threaded through the tissue 2330′, for example using one ormore medial stitches 2342 a′, 2342 b′.

The patch 2310′ can have similar properties as the patch 2310 and can bethreaded onto suture limbs 2312 a′, 2312 b′, 2316 a′, 2316 b′ usingtechniques provided for throughout the present disclosure. The patch2310′ can subsequently be advanced along the suture limbs 2312 a′, 2312b′, 2316 a′, 2316 b′ until the proximal end 2310 p′ is proximate themedial stitches 2342 a′, 2342 b′, as shown in FIGS. 32G and 32H. Afterthe patch 2310′ has been installed on the suture limbs 2312 a′, 2312 b′,2316 a′, 2316 b′, the free ends of each of the suture limbs 2312 a′,2316 b′ and 2312 b′, 2316 a′ can then be installed into respectivelateral anchors 2362 a′ and 2362 b′ in a lateral row fixation. Thesuture limbs 2312 a′, 2312 b′, 2316 a′, 2316 b′ can then be tightened tosecure the patch 2310′ against the repair 2340′ before the lateralanchors 2360 a′, 2360 b′ are fully fixed in the bone 2350′. The samebenefits described above with respect to the method of using the patch2210′ are equally applicable to the embodiments of using the patches2310 and 2310′, including the benefits resulting from the crossed natureof the suture configuration. Additional benefits of these twoembodiments will also be clear to those having skill in the art in viewof the present disclosures.

The patch 2310 can be manufactured using a number of differenttechniques, some of which have been previously discussed above at leastwith regards to the tissue augmentation blocks 10, 110 and otherconstructs. The patch 2310, and thus also the patch 2310′, can be madefrom any of the materials provided for above with respect to the tissueaugmentation blocks 10, 110, 3010, 3110, 310, and 410, and/or otherconstructs described herein. In one exemplary embodiment of making apatch, illustrated by FIGS. 32I and 32J, the material being used to makethe patch 2310 can be harvested or otherwise acquired using the sametechniques as described above with respect to the patch 2210. As shownin FIG. 32I, the piece of material 2320 can have a first end 2320 a anda second end 2320 b with the width 2W_(P)′ extending therebetween.Alternatively, the piece of material 2320 can have any shape.

Once the piece of material 2320 has been cut out, the two ends 2320 a,2320 b, can be folded over approximately ¼ of the width 2W_(P)′ awayfrom the first and second ends 2320 a, 2320 b, respectively, and broughtproximate to one another and subsequently attached to each other,thereby forming the patch 2310. As shown in FIG. 32J, the patch 2310 isstitched together to form the folded patch. The stitching 2324 a-2324 dis performed such that the two parallel lumens 2314 a, 2314 b arecreated in combination with the X shaped lumens 2314 c, 2314 d. Thefirst stitch 2324 a can be substantially V-shaped, having both endslocated at the distal most end 2310 d of the patch 2130 and the vertexof the V-shape pointing towards the proximal most end 2310 p of thepatch 2130. The second stitch 2324 b can be substantially V-shaped,having both ends located at the proximal most end 2310 p of the patch2130 and the vertex of the V-shape pointing towards the distal most end2310 d of the patch 2130. The third and fourth stitches 2324 c, 2324 dcan be substantially triangular in shape and can be substantially mirrorimages of the other to define the lumens 2314 a, 2314 d. Alternatively,pins can be placed along where the lumens 2314 a-2314 d are to belocated, and then the patch 2310 can be stitched together to manufacturethe patch 2310. The pins can be removed once the patch is manufactured.Further alternatively, in place of stitches the material 2320 can besecured to itself with the use of glue, collagen bond, staples, lightcuring, or other techniques for attaching soft tissue to soft tissueknown to those skilled in the art and provided for throughout thepresent disclosure.

In embodiments that include threaders predisposed in the patch 2310,threaders 2306 a-2306 d can be inserted into the lumens 2314 a-2314 dbefore the two ends 2320 a, 2320 b are attached, or after. The patch2320 can be dried for packaging at any suitable point during themanufacturing process. Further alternatives for forming the patch 2310in accordance with the present disclosures include but are not limitedto harvesting a piece of material and using pins to pierce or punctureit to create the lumens 2314 a-2314 d, as described at least withrespect to FIGS. 30C-30E, and/or using a coring device or tube to createthe lumens 2314 a-2314 d, as described at least with respect to FIGS.26A-26I.

Many more configurations of patches and sutures are within the scope ofthe present disclosures. Configurations can be derived from makingadjustments to various parameters or variables provided for anddiscussed throughout the present application. Some parameters orvariables that can be changed to provide for various configurationsinclude: (1) the number of layers used to form the patch (e.g., onelayer, two layers); (2) the orientation of a first set of suture limbswith respect to each other and the patch (e.g., across the patch in amanner in which the limbs are not intersecting, across the patch in amanner in which the limbs intersect each other); (3) a location of asecond set of suture limbs with respect to the patch (e.g., on top ofthe patch, through the patch); (4) the orientation of the second set ofsuture limbs with respect to each other and the patch (e.g., across thepatch in a manner in which the limbs are not intersecting, across thepatch in a manner in which the limbs intersect each other); (5) theinclusion of one or more “stitches” with the first set of suture limbs,referred to herein as “loops” and “jogs,” to fixate the patch withrespect to at least one suture limb; (6) whether the second set ofsuture limbs is disposed in lumens formed in the patch; (7) whetheradditional sutures are provided (e.g., medial center suture, lateralcenter suture); and (8) a location of the first set of suture limbs withrespect to the second set of suture limbs (e.g., inside of the secondset of suture limbs, outside of the second set of suture limbs).

A small sample of some patch configurations illustrating options for theabove-listed parameters or variables is shown in FIGS. 33A-33E. Someconfigurations can be better than others in aiding patch delivery and/oraiding the attachment of the patch to soft tissue. One skilled in theart will understand that the various parameters can be mixed and matchedto arrive at a large number of configurations, many of which are notexplicitly illustrated herein, but are derivable based on theunderstanding provided about each of the variables and the constructsmore generally as disclosed in the present application. To assist inunderstanding some of the options associated with the above-listedparameters, each parameter is discussed in more detail below with alimited number of example configurations illustrated. However, it iscontemplated that the instant disclosure encompasses each discretecombination of parameters in conjunction with many of the differentpatch configurations provided for in the present disclosure. Further,like reference numbers are used across each of the examples illustratedin FIGS. 33A-33E as the parameters are interchangeable across variousconfigurations using the same materials (e.g., patch, sutures, andanchors).

One parameter that can be changed to achieve various patchconfigurations is the number of layers that form each patch. Forexample, each patch can include a single layer of material with lumensbeing formed in the single layer for disposing suture limbstherethrough, as illustrated in FIGS. 26D-26F, 30A, 30B, and 31A-31C.The single layer can include a tissue-facing or tissue-engaging surface,also referred to herein as a bottom side 3410 d of the patch 3410, and asecond surface that is opposed to the tissue-facing surface (e.g., thesurface that is visible in FIGS. 33A-33E), also referred to herein as atop side 3410 p of the patch 3410. Alternatively, each patch can includetwo or more layers of material stitched together to form a single patchwith lumens being formed between two or more layers for disposing suturelimbs therethrough, as illustrated in FIGS. 32A-32J. When a second layeris used, each layer includes a tissue-facing surface and a secondsurface that is opposed to the tissue-facing surface. In suchembodiments, the tissue-facing surface of the patch is formed by thetissue-facing surface of the bottom, or more distal, patch, and thesecond surface of the patch that is opposed to the tissue-facing surfaceis formed by the second surface of the top, or more proximal, patch.Even in patches that include multiple layers, a lumen can be formed in asingle layer. In embodiments where the patch includes two layers, thestitching can form lumens as described with reference to FIGS. 32A-32J.For the sake of simplicity, a first set of suture limbs 3412, 3414 and asecond set of suture limbs 3416, 3418 will be referenced in thefollowing discussion, however a single set may be used. As discussedabove, in embodiments where two layers of material are used, each layercan be formed from different materials to provide a variety ofadvantages, including but not limited to: the overall thickness of thepatch configuration may not limited by a biological source, a level ofcellular activity can be controlled (e.g., a high tissue integrationlayer on a tissue facing side and an adhesion barrier layer on theopposite side), and other material characteristics can be varied betweeneach layer (e.g., toughness, biologic/synthetic, thick/thin,high-/low-porosity, etc.).

As shown in FIG. 33A, two inverted mattress stitches 3440 a, 3440 b canbe formed in the soft tissue, medial to any repairs (the repairs notbeing shown). More particularly, a first suture 3411 a can be used toform a first inverted mattress stitch 3440 a and a second suture 3411 bcan be used to form a second inverted mattress stitch 3440 b. The firstmattress stitch 3440 a can result in suture limb 3412 and suture limb3416 extending therefrom, and the second mattress stitch 3440 b canresult in suture limb 3414 and suture limb 3418 extending therefrom. Forthe purposes of discussion only, suture limbs 3412 and 3414 are definedas a first set of suture limbs, and suture limbs 3416 and 3418 aredefined as a second set of suture limbs. For the sake of simplicity,each of the embodiments shown in FIGS. 33A-33E illustrates two mattressstitches and therefore a discussion will not be repeated for eachfigure.

Further, as shown in each embodiment, the suture limbs 3412, 3414 of thefirst set of suture limbs are generally through the patch 3410. This caninclude configurations in which the suture limbs 3412, 3414 extendthrough the patch 3410 for an entire length of the patch, that is fromthe medial edge 3410M to the opposed lateral edge 3410L, orconfigurations in which the suture limbs 3412, 3414 extend through thepatch 3410 for a portion of the length. Generally the suture limbs 3412,3414 extend along a length that extends substantially between the medialand opposed lateral edges 3410M, 3410L. For example, as shown in FIG.33D, the suture limbs 3412, 3414 do not extend the entire length of thepatch 3410, but do extend a substantial portion of that length. Thesubstantial portion of the length can be at least about 50 percent ofthe length, or alternatively at least about 75 percent of the length, orfurther alternatively at least about 90 percent of the length.

As the suture limbs 3412, 3414, and the suture limbs 3416, 3418 arepassed through the patch, they are passed by leading a terminal end ofthe suture limb through, above, and/or below a portion of the patch3410. The terminal end that is described as being passed through thepatch in the illustrated embodiments can be considered a terminallateral end since that is the end that is being passed towards thelateral edge 3410L and towards illustrated anchors 3460 a, 3460 b. Whenterminal lateral ends are described as being coupled to an anchor, aperson skilled in the art will recognize that it is not the terminallateral end of the suture limb itself that necessarily is attached tothe anchor because when associating a suture with an anchor, theterminal end may extend some distance beyond the anchor, for instance asa result of tying the suture to the anchor. Thus, a description of aterminal lateral end of a suture limb being attached or otherwisecoupled to an anchor does not require that the very end of the sutureitself is touching or coupled directly to the anchor. Rather, it justindicates that some portion of that limb that a person skilled in theart would understand in view of the present disclosure qualifies as aterminal end of the system when forming the patch-suture configurationis the described terminal lateral end. Further, as shown, the anchors3460 a, 3460 b are disposed on opposite sides of a central longitudinalaxis 3410 c extending between the medial and lateral sides 3410M, 3410Lof the patch 3410. Generally, when the terminal lateral ends of thevarious suture limbs are being associated with the anchor, the terminallateral ends can be described as being proximate to each other. A personskilled in the art will recognize that even if the terminal lateral endsare associated with different anchors on the same side of the scaffold,and/or associated with one or more other fixtures (including but notlimited to bone, tissue, and medical implants) on the same side of thescaffold, the terminal lateral ends of the suture limbs on that side canstill be described as being proximate to each other in view of thepresent disclosure.

A second parameter that can be changed to achieve various patchconfigurations relates to the orientation of the first set of suturelimbs with respect to each other and the patch. For example, each of thefirst set of suture limbs 3412, 3414 can be disposed across the patch3410 from a medial edge 3410M to a lateral edge 3410L in a manner suchthat the limbs do not intersect each other, as shown in FIG. 33A. In theillustrated embodiment, the limbs 3412, 3414 extend substantiallyparallel to respective outer side edges 3410S, 3410T of the patch 3410and are disposed on separate halves of the central longitudinal axis3410 c. This configuration can provide for added securement of the edges3410S, 3410T when the limbs 3412, 3414 are extended over the edges. Aperson skilled in the art will recognize that the limbs 3412, 3414 canbe oriented in many other manners with respect to each other and thepatch 3410 without causing them to intersect. For example, the first setof suture limbs 3412, 3414 can be disposed across the patch 3410 fromthe medial edge 3410M to the lateral edge 3410L in a manner such thatthe limbs extend substantially straight across the patch 3410 and arethus substantially parallel to one another. Examples of limbs configuredin such a manner are illustrated at least in FIGS. 30A-30L (e.g., limbs2212 a and 2212 b, limbs 2212 a′ and 2216 a′, and limbs 2212 a″ and 2216a″).

In a further alternative, the first set of suture limbs 3412, 3414 canbe disposed across the patch 3410 from the medial edge 3410M to thelateral edge 3410L in a manner such that the limbs do intersect eachother. For example, the limbs 3412, 3414 can be disposed across thepatch 3410 to form an “X” configuration or shape, like the limbs 2212 b′and 2216 b′ of FIG. 30I, the limbs 2312 b, 2316 b of FIGS. 32A-32E, thelimbs 2312 b′, 2316 b′ of FIGS. 32F-32H, and limbs 3416 and 3418 of FIG.33B (which are described as the second set of limbs but are referencedfor purposes of generally showing an intersecting configuration). Thisconfiguration can provide for a more distributed compression over alarger area of the construct. A person skilled in the art will recognizethat the limbs 3412, 3414 can be oriented in many other manners withrespect to each other and the patch 3410 while still intersecting eachother. Further, to the extent the limbs 3412, 3414 are described asbeing disposed across the patch, they can extend across a top surface ofthe patch, through the patch (e.g., through a single layer, disposedbetween two layers), or a combination of both across the top surface ofthe patch and through the patch. Additionally, the limbs 3412, 3414 donot have to be oriented in a similar manner. For example, the limb 3412can extend substantially parallel to the outer side edge 3410S, orextend substantially straight across the patch 3410 with the limb 3412remaining on one side of the central longitudinal axis 3410 c, while thelimb 3414 extends more diagonally such that it crosses over the centrallongitudinal axis 3410 c.

A third parameter that can be changed to achieve various patchconfigurations relates to a location of a second set of suture limbswith respect to the patch. For example, the second set of suture limbs3416, 3418 can be disposed through the patch as they extend from themedial edge 3410M to the lateral edge 3410L, similar to the orientationof the limbs 2312 b and 2316 b and limbs 2312 b′ and 2316 b′ of FIGS.32A-32J. Advantageously, when at least one suture limb is disposedthrough the patch, the patch can be more secure after installation.Alternatively, the second set of suture limbs 3416, 3418 can be disposedover a top surface of the patch 3410, similar to the orientation of thelimbs 2212 b and 2216 b, limbs 2212 b′ and 2216 b′, and limbs 2212 b″and 2216 b″ of FIGS. 30A-30L. In some instances, some portion of anysecond limbs can extend through the patch while some other portionextends on top of the patch, and the configuration of this parameter forany limb does not have to be the same as any other limb.

A fourth parameter that can be changed to achieve various patchconfigurations relates to the orientation of the second set of suturelimbs with respect to each other and the patch. For example, each of thesecond set of suture limbs 3416, 3418 can be disposed across the patch3410 from the medial edge 3410M to the lateral edge 3410L in a mannersuch that the limbs do not intersect each other, or in a manner suchthat they do intersect. Such configuration possibilities are similar tothose discussed above with respect to the second parameter, which wasfor the orientation of the first set of suture limbs with respect toeach other and the patch. Further, in some instances the second suturelimbs 3416, 3418 may not extend over or through the patch 3410, butrather, may extend around and/or adjacent to the patch 3410. Firstsuture limbs 3412, 3414 can also be configured in a manner in which atleast a portion of them extend around and/or adjacent to the patch 3410rather than on top of or through the patch.

By way of non-limiting example, FIG. 33A illustrates an embodiment inwhich the second set of limbs 3416, 3418 do not intersect and extendaround and adjacent to the patch 3410; thus, the limbs 3416, 3418 do notextend over or through the patch 3410. By way of further non-limitingexamples, FIGS. 33C and 33E each illustrate embodiments in which thesecond set of limbs 3416, 3418 do not intersect and extend on top of thepatch 3410. As shown in FIG. 33D, it is possible to combine variousorientations across the length extending between the medial and lateraledges 3410M and 3410L. For example, as shown the limbs 3416, 3418 do notintersect, but the orientation of the limbs with respect to the patch3410 changes as the limbs extend between the medial and lateral edges3410M and 3410L. More particularly, as shown, a first portion 3416 p ₁,3418 p ₁ of each of the limbs 3416, 3418 extends around and/or adjacentto the patch 3410, a second portion 3416 p ₂, 3418 p ₂ of each of thelimbs 3416, 3418 extends on top of the patch 3410, and a third portion3416 p ₃, 3418 p ₃ of each of the limbs 3416, 3418 extends through thepatch 3410. The orientation of the first set of suture limbs 3412, 3414can likewise have different configurations across their length.

FIG. 33B, on the other hand, provides for an embodiment in which thesecond set of suture limbs 3416, 3418 do intersect. As shown, the limbs3416, 3418 are disposed across the patch 3410 (as shown, through thepatch), to form an “X” configuration or shape, like the limbs 2212 b and2216 b′ of FIG. 30I, the limbs 2312 b, 2316 b of FIGS. 32A-32E, and thelimbs 2312 b′, 2316 b′ of FIGS. 32F-32H. An “X” configuration canprovide for a more distributed compression over a larger area of theconstruct. A person skilled in the art will recognize that the limbs3416, 3418 can be oriented in many other manners with respect to eachother and the patch 3410 while still intersecting each other. Further,while in the illustrated embodiment of FIG. 33B the limbs 3416, 3418extend through the patch 3410, they can also extend across a top surfaceof the patch and/or around or adjacent to the patch, or any combinationthereof. Likewise, limbs extending through the patch can extend througha single layer and/or be disposed between two layers.

A fifth parameter that can be changed to achieve various patchconfigurations relates to the inclusion of one or more “stitches” inconjunction with the first set of suture limbs. As described in thepresent disclosure, these “stitches” can be referred to as “loops,” asshown and described with respect to FIG. 33C, and “jogs,” as shown anddescribed with respect to FIG. 33D. As described in greater detailbelow, the stitches for loops and jogs both involve passing a terminalend of the suture limb through at least a portion of the patch (e.g.,through a proximal-most surface of the patch) and then to and throughthe lateral edge of the patch. Loops can involve the suture limb passingan entire length of the patch extending between the medial and lateraledges, while jogs can involve the suture limb passing through a portionof the length that is not necessarily the entire length (although it canbe a substantial portion of the length). The loops and jogs are used tohelp fixate the patch with respect to at least one suture limb.

As illustrated in FIG. 33C, a loop stitch or loop 3444 a can be formedby passing a suture limb 3412 from the bottom side 3410 d of the patch3410, which faces the soft tissue 3430, to the top side 3410 p of thepatch 3410 at a location 3408 a proximate to the medial edge 3410M. Thelocation 3408 a can be a preformed lumen, or it can be a lumen formedwhile advancing the suture limb 3412 through the patch 3410, forinstance because the material of the patch 3410 is braided such that thelimb 3412 can be passed through it. The patch 3410 can include at leastone lateral lumen 3407 a, 3407 b that extends from the medial edge 3410Mto the lateral edge 3410L. Alternatively, the lumens 3407 a, 3407 b maynot be preformed or exist and may instead just be locations within thepatch 3410 through which filament can be passed, for instance betweentwo layers or through a single layer that has a material conducive tohaving a material passed therethrough. The suture 3412 can then bethreaded medially to enter the lumen 3407 a at the medial edge 3410M andextend through the lumen to the lateral edge 3410L. Once tension isapplied to the loop 3444 a and the loop is brought into contact with thepatch 3410, the suture limb 3412 can be fixed relative to the patch 3410such that the patch 3410 will not drift along the suture 3412 afterimplantation. The loop 3444 a can also provide for additional stabilityduring patch installation. This process can be repeated for suture limb3414 to form a second loop stitch or loop 3444 b. The loops 3444 a, 3444b can be formed in vivo, or alternatively can be formed before the patchis introduced into the surgical site using patch delivery systemsdescribed below. The free end of each suture limb 3412, 3416 and 3414,3418, also referred to herein as terminal lateral ends, can then besecured within the body using techniques provided for throughout thepresent disclosure. For example, as shown in FIG. 33C, the free ends ofeach suture limb 3412, 3416 and 3414, 3418 can be coupled to lateralanchor 3460 a and 3460 b, respectively, in a lateral row fixation. Thesuture limbs 3412, 3414, 3416, 3418 can then be tightened to secure thepatch 3410 against the repair before the lateral anchors 3460 a, 3460 bare fully fixed in the bone 3450.

Alternatively, in place of a loop, the suture limb 3412 of the first setof suture limbs 3412, 3414 can be used to form a jog. As illustrated inFIG. 33D, a jog stitch or jog 3446 a can be formed by passing the suturelimb 3412 from the bottom side 3410 d of the patch 3410 to the top side3410 p of the patch 3410 at a location 3408 a proximate to the medialedge 3410M, and then advancing the suture limb 3412 towards the outeredge 3410S before passing the suture limb 3412 back into the patch 3410from the top side 3410 p and towards the bottom side 3410 d. The suturelimb 3412 can then be advanced towards the lateral side 3410L. In theillustrated embodiment, the suture limb 3412 is passed through a laterallumen 3407 a that extends from the medial edge 3410M to the lateral edge3410L. Alternatively, the lumen 3407 a, and/or its illustratedcounterpart lumen 3407 b, may not be preformed or exist and may insteadjust be locations within the patch 3410 through which filament can bepassed, for instance between two layers or through a single layer thathas a material conducive to having a material passed therethrough. Likewith the embodiment in FIG. 33C, the location 3408 a can be a preformedlumen, or it can be a lumen formed while advancing the suture limb 3412through the patch 3410, for instance because the material of the patch3410 is braided such that the limb 3412 can be passed through it. Asshown, the portion of the limb 3412 extending through the patch 3410extends a substantial portion of the length of the limb that extendsbetween the medial and lateral edges 3410M and 3410L, but not the entirelength.

When forming the jog 3446 a, the suture 3412 can be advanced towards theouter edge 3410S any desired distance based, at least in part, on thesize of the patch 3410 and desired configuration of the patch and suturecombination. By way of non-limiting example, in some embodiments the jog3446 a can extend substantially perpendicular to the centrallongitudinal axis 3410 c and can have a length approximately in therange of about 1.0 millimeters to about 5.0 millimeters away from thelocation 3408 a. Once tension is applied to the jog 3446 a and the jog3446 a is brought into contact with the patch 3410, the suture limb 3412can thus be fixed relative to the patch 3410 such that the patch 3410will not drift along the suture limb 3412 after implantation. The jog3446 a can also provide for additional stability during patchinstallation. A second jog stitch 3446 b can be formed with the secondlimb 3414. The jog stitches 3446 a, 3446 b can be formed in vivo, oralternatively can be formed before the patch 3410 is introduced into thesurgical site using patch delivery systems described below. Alternately,the two sutures of the first set of sutures 3412, 3414 can be associatedwith the patch 3410 with different stitches, or no additional stitches.Further, in some instances, a combination of loops and jogs can be used.

A sixth parameter that can be changed to achieve various patchconfigurations relates to whether the second set of suture limbs isdisposed in lumens formed in the patch, or alternatively, throughportions of the patch through which the first set of suture limbs ispassed. One illustration of such a configuration is illustrated in FIG.33D. As shown, the second set of suture limbs 3416, 3418 can beintroduced into the respective lumens 3407 a, 3407 b of the patch 3410,along with one of the suture limbs 3412, 3414 of the first set of suturelimbs. This occurs at a location 3409 a, 3409 b that is lateral to themedial edge 3410M of the patch 3410. This configuration of the secondset can provide for a further securing of the patch in ananterior-posterior direction. A person skilled in the art will recognizea location at which the second, or first, set of suture limbs isdisposed within the patch 3410 can vary without departing from thespirit of the present disclosure.

A seventh parameter that can be changed to achieve various patchconfigurations is the inclusion of additional sutures, such as centralmedial sutures or central lateral sutures, to provide additionalsecurement of the patch at discrete locations from the lumens. Forexample, as shown in FIG. 33E, one or more central medial invertedmattress stitches 3470 can be made in the soft tissue 3430 medial to thepatch 3410. In the illustrated embodiment, the stitch 3470 isapproximately in-line with the first and second mattress stitches 3440a, 3440 b, although other configurations, locations, and number ofstitches are possible without departing from the spirit of the presentdisclosure. The central medial inverted mattress stitch 3470 can begenerally aligned with a center of the patch 3410 in some instances,such as the illustrate embodiment. The central medial stitch 3470 canresult in suture limbs 3472 a, 3472 b extending therefrom. The suturelimbs 3472 a, 3472 b can be disposed over a proximal face 3410 p of thesuture patch 3410 and secured with suture anchors 3460 a, 3460 b,respectively, according to techniques provided for herein.

Alternatively, or in addition to the central medial inverted mattressstitch 3470, a central lateral mattress stitch 3474 can be pre-loadedonto the patch at a location in the lateral half of the patch.Alternatively, the central lateral mattress stitch 3474 can be formed inthe patch 3410 in vivo. The central lateral mattress stitch 3474 can begenerally aligned with a center of the patch 3410. Like the medialinverted mattress stitch, a number of different configurations,locations, and number of stitches are possible, and in the illustratedembodiment the inverted mattress stitch 3474 results in suture limbs3476 a, 3476 b extending from the patch 3410. In the illustratedembodiment, the suture limbs 3476 a, 3746 b are disposed over theproximal face 3410 p of the suture patch 3410 and are additionallysecured in suture anchors 3460 a, 3460 b. Both the central medial stitchand lateral central stitch can provide for additional compression of thepatch against the soft tissue to aid in healing. While the patch 3410illustrated in FIG. 33E illustrates both a central medial mattressstitch and a central lateral mattress stitch in the same embodiment, inother embodiments only one or neither may be provided. Further, otherlocations for additional stitches are also possible without departingfrom the spirit of the present disclosure.

An eighth parameter that can be changed to achieve various patchconfigurations is a location of the first set of suture limbs withrespect to the second set of suture limbs. More particularly, thisparameter relates to whether the limbs of the first set of suture limbsare disposed inside or outside of the limbs of the second set of suturelimbs, where outside represents being further from the centrallongitudinal axis 3410 c. In the embodiments illustrated in FIGS. 33Aand 33D, the first set of suture limbs is disposed inside of the secondset of suture limbs, while in the embodiments illustrated in FIGS. 33B,33C, and 33E, the first set of suture limbs is disposed outside of thesecond set of suture limbs. More particularly with respect to FIG. 33D,the first set of suture limbs is disposed inside the second set ofsuture limbs until they converge at the location 3409 a, at which pointthey are substantially aligned. Thus, the orientation of the first setof suture limbs with respect to the second set of suture limbs canchange between the medial and lateral edges 3410M, 3410L, includinghaving some portion that is inside the other and some portion that isoutside of the other. Further, a person skilled in the art willrecognize that not each limb of the set of limbs needs to be disposed inthe same respect, meaning that some limbs of the first set of limbs canbe disposed inside of one or more limbs of the second set of limbs, andlikewise some limbs of the first set of limbs can be disposed outside ofone or more limbs of the second set of limbs in the same patchconfiguration.

Notably, most any of the aforementioned parameters or variables can bemixed and matched in one or more patch configurations without departingfrom the spirit of the present disclosure. Accordingly, there are manydifferent configurations that can result from the present disclosure.The term “most any” is used because a person skilled in the art willrecognize that, depending on the value of some of these parameters, someof the other parameters may not be adjustable, and a person skilled inthe art will recognize as such in view of the present disclosures andthe skilled person's knowledge. FIGS. 33A-33E represent a small samplingof possible configurations intended to illustrate various configurationsbased on the eight parameters identified in the present disclosure. Eachof the illustrated configurations can be used in conjunction withvarious procedures. FIG. 33C represents one particularly usefulconfiguration in that it provides for the stability provided for by theloops 3444 a, 3444 b, provides for a configuration in which the firstset of limbs are disposed approximately straight through the patch 3410to provide additional securement of the edges 3410S, 3410T. Further, theconfiguration is additionally particular useful because the second setof limbs are disposed approximately straight (as opposed to crossed inan “X” configuration or shape) over the patch 3410 to aid in themedialization of the patch and ease of tensioning of the limbs, the fourlimbs decrease the likelihood of undesirable “cheese-wiring,” and theconfiguration does not include additional stitches or the like, makingit easier and/or quicker to perform than some options that includeadditional stitches.

Still another exemplary embodiment of a tissue augmentation construct2410 having a patch or scaffold configuration is illustrated in FIGS.34A and 34B. As shown, the patch 2410 has a rectangular-shaped bodyhaving generally rounded corners. Alternatively, the patch 2410 can haveany shape, for example circular. The patch 2410 can be disposed on orotherwise associated with sutures 2412, 2416. As shown, the patch 2410has a length L_(P)″ that is substantially equal to a width W_(P)″, andit also has a thickness T_(P)″.

A person skilled in the art will recognize that the dimensions of thelength L_(P)″, the width W_(P)″, thickness T_(P)″ of the augmentationpatch 2410 can depend on a variety of factors, including but not limitedto the size of the filament with which it is to be associated, theanatomy of the patient, and the type of procedure being performed. Theexemplary, non-limiting dimensions provided above for the patch 2210 canalso be applicable to the size of the patch 2410, with the understandingthat other dimensions are possible. Likewise, a number of techniquesknown to those skilled in the art can be used to associate theaugmentation patch 2410 with the sutures 2412, 2416. Nevertheless, FIGS.34A and 34B illustrate one exemplary method for using suture threaders2406 a, 2406 b to associate the patch 2410 with the sutures 2412, 2416.

As shown in FIGS. 34A and 34B, the sutures limbs 2412, 2416 are threadedto the patch 2410 at medial locations 2411 a, 2411 b of the patch,respectively, to secure the sutures 2412, 2416 relative to the patch2410 in a pre-installation configuration. In the illustrated embodimentthe medial locations 2411 a, 2411 b are located approximately midwaybetween opposing sides 2410 a, 2410 b of the patch 2410, although otherlocations are possible. The sutures 2412 and 2416 can be stitched, orotherwise threaded, onto the patch 2410 such that two suture limbs 2412a, 2412 b and 2416 a, 2416 b, respectively, extend from a proximalsurface of the patch 2410. The suture limb 2412 a and 2416 a can eachhave a first portion that includes a hollow self-locking mechanism 2470a and 2470 b having a lumen 2472 a and 2472 b extending therethrough. Inthe illustrated embodiment the self-locking mechanisms 2470 a, 2740 bare finger-trap-like configurations, although other self-lockingmechanisms provided for herein or otherwise known to those skilled inthe art in view of the present disclosures can also be used.

The self-locking mechanisms 2470 a and 2470 b can each have a lengththat is less than the distance extending between the side 2410 a of thepatch 2410 and the respective stitches 2411 a and 2411 b. The suturethreaders 2406 a, 2406 b can be inserted through the respectiveself-locking mechanisms 2470 a, 2470 b such that a proximal handleportion 2408 a, 2408 b is located proximate to the respective mediallocations 2411 a, 2411 b, and the distal suture-receiving ends 2409 a,2409 b are located more proximate to the side 2410 a than the side 2410b. The suture limbs 2412 a, 2416 a can have respective leading tails2413 a, 2413 b extending from the self-locking mechanisms 2470 a, 2740b. As shown, the leading tail 2413 a, 2413 b of each suture 2412, 2416can be threaded from a proximal side 2410 p to the distal side 2410 d ofthe patch 2410, at a location that is more proximate to the side 2410 athan the side 2410 b. Further, as illustrated, the suture limbs 2412 b,2416 b are threaded from the proximal side 2410 p to the distal side2410 d of the patch 2410, at a location that is more proximate to theside 2410 b than the side 2410 a, thereby forming trailing tails. Aperson skilled in the art will recognize a variety of other ways bywhich the patch 2410 can be associated with the sutures 2412, 2416without departing from the spirit of the present disclosure.

FIGS. 34C-34J provide for one exemplary method of installing the tissueaugmentation patch 2410 to help secure a piece of soft tissue 2430,e.g., rotator cuff, to bone 2450 using a single row repair 2432. Likethe many other methods provided for herein, the patch 2410 and relatedtechniques can also be used in other types of repairs, such as doublerow repairs. Once the surgeon has access to the surgical site and thetissue, bone, and tissue augmentation patch have been prepared accordingto accepted surgical techniques including those provided for herein, asshown in FIG. 34C, the tissue 2430 can be fixed to the bone 2450 using asuture 2403 coupled to an anchor 2404 that inserted into the bone 2450.While one suture 2403 and one anchor 2404 are shown, a plurality can beused in order to effectively fix the tissue 2430 relative to the bone2450. Further, in the illustrated embodiment only the componentsassociated with one of the threaders and sutures is visible because ofthe point of view illustrated, but a person skilled in the art willunderstand that the other threader and suture can be operated in asimilar manner. Reference may be made to both components, even thoughonly one is visible, for ease of description.

Once the tissue 2430 has been fixated to the bone 2450, the leadingtails 2413 a, 2413 b can be stitched into the tissue, medial of therepair, as shown in FIG. 34D. In the illustrated embodiment, the leadingtails 2413 a, 2413 b are threaded into, and back out of, the tissue 2430using, for example, a mattress stitch 2442 a. As shown in FIG. 34E, theleading tail 2413 a can be coupled to the suture-receiving end 2409 a ofthe suture threader 2406 a, and the suture threader 2406 a can besubsequently operated as provided for in the present disclosure toadvance the leading tail 2413 a into the lumen 2472 a of theself-locking mechanism 2470 a. A similar action can be taken withrespect to the leading tail 2413 b so that it becomes disposed in thelumen 2472 b of the self-locking mechanism 2470 b, although, asindicated above, this is not visible in the point of view illustrated.After distal ends of the tails 2413 a, 2413 b have been passed throughthe respective self-locking mechanisms 2470 a, 2740 b such that thedistal ends are visible and able to be grabbed by a user, as shown inFIG. 34F, the threaders 2406 a, 2406 b can be disconnected from thetails 2413 a, 2413 b and disposed of and/or prepared for future use. Inthe illustrated embodiment, the self-locking mechanisms 2470 a, 2470 bcan operate such that the respective leading tails 2413 a, 2413 b canonly advance in one direction, or can optionally be selectivelylockable.

As shown in FIG. 34G, the operator can apply a force F_(P) to theleading tails 2413 a, 2413 b to advance the patch 2410 towards themattress stitch 2442 a. More specifically, as the force F_(P) is appliedto the leading tail 2413 a, a loop 2415 a defined by the self-lockingmechanism 2470 a is collapsed, as illustrated by the resultingconfiguration in FIG. 34H. A similar result occurs when the force F_(P)is applied to the leading tail 2413 b.

The patch 2410 is an installed location, as shown in FIG. 34H, when therepair 2432 has been covered by the patch 2410. More particularly, theillustrated installed configuration shows that the side 2410 a of thepatch 2410 is proximate to the mattress stitch 2442 a. As a result, whenthe side 2410 b of the patch 2410 is coupled to a location in the body,the patch 2410 is able to bend over as shown and more securely protectand integrate with the tissue 2430. This is because the patch 2410 canstretch to provide for a tighter fit. The patch 2410, in combinationwith the sutures 2412, 2416, operate together as a single continuoussuture or belt, which can better share the load than using multiplestitches. A person skilled in the art will recognize that other lengthsof the patch 2410, other locations for the medial stitches 2411 a, 2411b, and other locations for a distal terminal end of the self-lockingmechanisms 2472 a, 2742 b, among other factors, can be adjusted toachieve other installed configurations in accordance with the presentdisclosures. Alternatively, the patch 2410 can be located medial to therepair 2432, or any other location that is desired for a givenprocedure.

Any number of techniques for securing a location of the side 2410 b ofthe patch 2410 within the body can be used, including those provided forherein. In the illustrated embodiment, after the patch 2410 has beeninstalled onto the tissue 2430, as shown in FIGS. 341 and 34J, theleading tail 2413 a and the trailing tail 2412 b are coupled to theanchor 2460 a and the leading tail 2413 b and trailing tail 2416 b arecoupled to the anchor 2460 b. The leading tails 2413 a, 2413 b and thetrailing tails 2412 b, 2416 b can then be tightened to secure the patch2410 against the repair before the anchors 2460 a, 2460 b are fullyfixed in the bone 2450. Once the patch 2410 is secured within the body,the patch 2410 does not generally flex much or move so that way thepatch 2410 can protect and heal in manners described throughout thepresent application with respect to augmentation constructs generally.Alternatively, the trailing tails 2412 b, 2416 b can both be secured tothe patch 2410 at a location proximate the anchors 2406 a, 2406 b toallow for the patch to stretch over the tissue.

In an alternative method, the leading tail 2413 b and the trailing tail2412 a can be coupled to the anchor 2460 a and the leading tail 2413 aand the trailing tail 2416 b can be coupled to the anchor 2460 b, asshown in FIG. 34K. Such a configuration provides for a crossed patternthat can provide benefits as described above when discussing crossedpatterns. In yet a further alternative embodiment, the leading tails2413 a, 2413 b can be cut proximate to where they exit the self-lockingmechanisms 2470 a, 2470 b, respectively, such that only the trailingtails 2412 b, 2416 b are secured into the anchors 2406 a, 2406 b,respectively. This is because in certain self-locking mechanismconfigurations, such as the finger-trap-like configuration illustrated,allows the trailing tails 2412 b, 2416 b to carry the load. A personskilled in the art, in view of the present disclosures, will furtherrecognize that various suture sizes and configurations can be adjustedin view of the flexible patch 2410 to help share the load.

The tissue augmentation patch 2410 can be manufactured using a number ofdifferent techniques which have been previously discussed above withregards to tissue augmentation constructs, including but not limited tothe tissue augmentation patches 2210, 2310. Further, the patch 2410 canbe made from any of the materials provided for above with respect to thepatches 2210, 2310, including materials that promote healing and tissuegrowth, for example collagen. As a result, while the patient is healingfrom the procedure, the patch can remodel into tendon-like tissue andintegrate with the underlying native tissue. The additional coverage oftendon like tissue across the soft tissue can increase the strength ofthe soft tissue to bone connection and may prevent further injury.

Another exemplary embodiment of a tissue augmentation construct 2510having a patch or scaffold configuration is illustrated in FIGS.35A-35D. The patch 2510 has a shape and size similar to that of thepatch 2410, and can be disposed on or otherwise associated with sutures2512 a, 2512 b, 2516 a, 2516 b. A number of techniques provided forthroughout the present disclosure can be used to couple or otherwiseassociate the patch 2510 with the sutures 2512 a, 2512 b, 2516 a, 2516b. As shown in FIG. 35A, the sutures 2512 a, 2516 a are threaded to thepatch 2510 at medial locations 2511 a, 2511 b of the patch,respectively, to secure the sutures 2512 a, 2516 a relative to the patch2510. The medial locations 2511 a, 2511 b, can be similar to thecomparable medial locations 2411 a, 2411 b of the patch 2410, and thuscan lead to some of the same benefits described above. The sutures 2512a, 2516 a can be stitched or otherwise fixed onto the patch 2510 suchthat the sutures 2512 a, 2516 a extend from a proximal surface of thepatch 2510. First portions of the sutures 2512 a, 2516 a can eachinclude a hollow self-locking mechanism 2570 a, 2570 b having a lumen2572 a, 2572 b extending therethrough. In the illustrated embodiment theself-locking mechanisms 2570 a, 2570 b are finger-trap-likeconfigurations, although other self-locking mechanisms provided forherein or otherwise known to those skilled in the art in view of thepresent disclosures can also be used.

The self-locking mechanisms 2570 a, 2570 b can have lengths that areless than the distance extending between the side 2510 a of the patch2510 and the respective medial locations 2511 a, 2511 b. Suture threader2506 a, 2506 b can be inserted through respective lumens 2572 a, 2572 bof the self-locking mechanisms 2570 a, 2572 b and can be configured in asimilar manner as the suture threaders 2406 a, 2406 b described above.The sutures 2512 a, 2516 a can include leading tails 2513 a, 2513 bwhich, as shown, can extend respectively from the self-lockingmechanisms 2570 a, 2570 b. As shown in FIGS. 35A and 35B, the leadingtails 2513 a, 2513 b are threaded from a proximal side 2510 p to thedistal side 2510 d of the patch 2510, at a location that is proximate tothe side 2510 a of the patch 2510.

Unlike the previous embodiment of the tissue augmentation construct 2410in which the trailing tails were part of the filament used to form theself-locking mechanisms and the leading tails, trailing tails of thetissue augmentation construct 2510 are separate filaments that are notpart of the filaments used to form the self-locking mechanisms 2570 a,2570 b or the leading tails 2513 a, 2513 b. As shown, the suture 2512 bis a trailing tail that includes a mattress stitch at a location that isproximate to the side 2510 b of the patch 2510, and the suture 2516 b isa trailing tail that includes a simple stitch at a location that is alsoproximate to the side 2510 b. More particularly, each of the trailingtails 2512 b and 2516 b pass from a proximal side 2510 p of the patch2510 to a distal side 2510 d of the patch 2510. By providing separateleading and trailing tails, a user can have additional control over theconstruct 2510 since the tails can operate independently. It can, forexample, enhance the stretching of the construct 2510 that occurs ateither end 2510 a, 2510 b. Notably, this embodiment illustrates somenon-limiting ways by which sutures can be associated with tissueaugmentation constructs, and thus in other embodiments both trailingtails 2512 b, 2516 b can use similar stitches. A person skilled in theart will recognize a variety of other ways by which the patch 2510 canbe associated with the sutures 2512 a, 2512 b, 2516 a, 2516 b withoutdeparting from the spirit of the present disclosure.

The method of installing the tissue augmentation patch 2510, which isillustrated in FIGS. 35C and 35D by way of an installed configuration,can be similar to the method described above with respect to the patch2410, and the installed configuration is illustrated without includingthe steps leading thereto. As shown, the medial locations 2511 a, 2511 bof the patch 2510 are proximate to an edge of the tissue 2530, and theedge 2510 b is disposed proximate to anchors 2560 a, 2560 b by way ofthe trailing tails 2512 b, 2516 b being coupled and tightened thereto.Alternatively, the patch 2510 can be located medial to the repair, orany other location that is required for the procedure.

Yet another exemplary embodiment of a tissue augmentation construct 2610having a patch or scaffold configuration is illustrated in FIGS.36A-36I. The patch 2610 has a shape and size similar to that of thepatches 2410 and 2510, and can be disposed on or otherwise associatedwith sutures 2612, 2616. A number of techniques provided for throughoutthe present disclosure can be used to couple or otherwise associate thepatch 2610 with the sutures 2612, 2616. As shown in FIG. 36A, thesutures limbs 2612, 2616 are threaded into the patch at medial locations2611 a, 2611 b of the patch 2610, respectively, to secure the sutures2612, 2616 relative to the patch 2610. The medial locations 2611 a, 2611b, can be similar to the comparable medial locations 2411 a, 2411 b ofthe patch 2410, and thus can lead to some of the same benefits describedabove.

The suture 2612 can be stitched or otherwise fixed onto the patch 2610such that two suture limbs 2612 a, 2612 b extend from a proximal surface2610 p of the patch 2610. Each of the suture limbs 2612 a and 2612 b canhave a first portion that includes a hollow self-locking mechanism 2670a, 2670 b having a lumen 2672 a, 2672 b extending therethrough,respectively. In the illustrated embodiment the self-locking mechanisms2670 a, 2670 b are finger-trap-like configurations, although otherself-locking mechanisms provided for herein or otherwise known to thoseskilled in the art in view of the present disclosures can also be used.

The self-locking mechanisms 2670 a, 2670 b can have lengths that areless than the distance extending between the respective sides 2610 a,2610 b of the patch 2610, as shown, and the medial location 2611 a.Suture threaders 2606 a, 2606 b can be inserted through respectivelumens 2672 a, 2672 b of the self-locking mechanisms 2670 a, 2672 b andcan be configured in a similar manner as the suture threaders 2406 a,2406 b described above. The suture limbs 2612 a, 2612 b can includeleading tails 2613 a, 2613 b which, as shown, can extend respectivelyfrom the self-locking mechanisms 2670 a, 2670 b. As shown in FIGS. 36Aand 36B, the leading tails 2613 a, 2613 b are threaded from the proximalside 2610 p to the distal side 2610 d of the patch 2610, at locationthat are proximate to the respective sides 2610 a, 2610 b of the patch2610.

The suture 2616 can be stitched or otherwise fixed onto the patch 2610in substantially the same manner as the suture 2612, and thus includesself-locking mechanisms 2670 c, 2670 d associated with suture limbs 2616a, 2616 b, with the self-locking mechanisms 2670 c, 2670 d havingleading tails 2613 c, 2613 d extending therefrom, respectively. As shownin FIG. 36A, the resulting patch 2610 can be symmetrical with regards toa first axis A₁ and a second axis A₂. A person skilled in the art willrecognize a variety of other ways by which the patch 2610 can beassociated with the sutures 2612, 2616 without departing from the spiritof the present disclosure.

FIGS. 36C-36I provide for one exemplary method of installing the tissueaugmentation patch 2610 to help secure a piece of soft tissue 2630,e.g., rotator cuff, to bone 2650 using a single row repair. Like themany other methods provided for herein, the patch 2610 and relatedtechniques can also be used in other types of repairs, such as doublerow repairs. Once the surgeon has access to the surgical site and thetissue, bone, and tissue augmentation patch have been prepared accordingto accepted surgical techniques including those provided for herein, asshown in FIG. 36C, the tissue 2630 can be fixed to the bone 2650 using asuture 2603 coupled to an anchor 2604 that inserted into the bone 2650.While one suture 2603 and one anchor 2604 are shown, a plurality can beused in order to effectively fix the tissue 2630 relative to the bone2650. Further, in the illustrated embodiment only the componentsassociated with one of the sutures is visible because of the point ofview illustrated, but a person skilled in the art will understand thatthe other suture and related components can be operated in a similarmanner.

Once the tissue 2630 has been fixated to the bone 2630, the leadingtails 2613 a, 2613 c can be stitched into the tissue, medial of therepair, as shown in FIG. 36C. As shown, the leading tail 2613 a isthreaded into, and back out of, the tissue 2630 using, for example, amattress stitch 2642 a. The leading tail 2613 a can then be coupled tothe distal suture-receiving end 2609 a of the suture threader 2606 a,and the suture threader 2606 a can be subsequently operated as providedfor in the present disclosure to advance the leading tail 2613 a intothe lumen 2672 a of the self-locking mechanism 2670 a, thereby forming aloop 2615 a. After the distal end of the tail 2613 a has been passedthrough the self-locking mechanisms 2670 a such that the distal end isvisible and able to be grabbed by a user, as shown in FIG. 36D, thethreader 2606 a can be disconnected from the tail 2613 a and disposed ofand/or prepared for future use. In the illustrated embodiment, theself-locking mechanism 2670 a can operate such that the leading tail2613 a can only advance in one direction, or can optionally beselectively lockable. The leading tail 2613 c can be similarly threadedthrough the self-locking mechanism 2670 c, in conjunction with thethreader 2606 c.

An anchor 2660 a can be inserted into the bone 2650, laterally offsetfrom the repair anchor 2604, having a collapsible loop 2662 a and atensioning tail 2664 a associated therewith. The tensioning tail 2664 acan be used to collapse the collapsible loop 2662 a towards the anchor2660 a. The leading tail 2613 c can be similarly threaded through theself-locking mechanism 2670 c, and a second lateral anchor 2660 b (FIG.36I) and collapsible loop (not visible) can be similarly installed intothe bone 2650.

As shown in FIGS. 36E and 36F, the trailing tail 2613 b can be loopedthrough the collapsible loop 2662 a and then coupled to the distalsuture-receiving end 2609 b of the suture threader 2606 b. The suturethreader 2606 b can be subsequently operated as provided for in thepresent disclosure to advance the trailing tail 2613 b into the lumen2672 b of the self-locking mechanism 2670 b, thereby forming a loop 2615b. After the distal end of the tail 2613 b has been passed through theself-locking mechanisms 2670 b such that the distal end is visible andable to be grabbed by a user, as shown in FIG. 36F, the threader 2606 bcan be disconnected from the tail 2613 b and disposed of and/or preparedfor future use. In the illustrated embodiment, the self-lockingmechanism 2670 b can operate such that the leading tail 2613 b can onlyadvance in one direction, or can optionally be selectively lockable. Theleading tail 2613 d can be similarly threaded through the self-lockingmechanism 2670 d, in conjunction with the threader 2606 d.

As shown in FIG. 36G, the collapsible loop 2662 a can be collapsedtowards the anchor 2660 a, thereby bringing a portion of the loop 2615 btowards anchor 2660 a. The trailing tail 2613 d can be similarly loopedthrough a collapsible loop (not shown) associated with the anchor 2660 bto bring a portion of that collapsible loop towards the anchor 2660 b,as seen at least in FIG. 36I.

As shown in FIG. 36H, the operator can apply a force F_(P) to theleading tail 2613 a, trailing tail 2613 b, leading tail 2613 c, andtrailing tail 2613 d to advance the patch 2610 towards the repair. Thepatch 2610 is in an installed location, shown in FIG. 36H, when therepair has been covered by the patch 2610, similar to the installedconfiguration described above with respect to the patch 2410, and whenslack in the loops 2615 a-2615 d has been removed. Thus, adjustments topositioning of the patch 2610 and related components can also beachieved in manners similar as described with respect to the patch 2410.After the patch 2610 has been installed onto the tissue 2630, as shownin FIGS. 36H and 36I, the excess portion of the tails 2613 a-2613 d thatextend out of the self-locking mechanisms 2670 a-2670 d can be cut toremove excess material.

Tissue Augmentation Patch Delivery Tools

Tools that aid in the delivery and suture management of tissueaugmentation constructs can reduce the complexity and time involved withthe procedures are also provided for in the present disclosure. Somesuch tools, including threaders and the installation tool 200′, areprovided for above. The disclosure in this section focuses on somedelivery tools that can be used in conjunction with patches orscaffolds, although a person skilled in the art will recognize how manydifferent constructs provided for herein can be used in conjunction withvarious delivery tools and systems provided for herein without departingfrom the spirit of the present disclosure. In other words, just becausethe disclosures provided below primarily illustrate delivery tools usedin conjunction with patches or scaffolds, other tissue augmentationconstructs can also be used in conjunction with delivery tools of thenature provided for, even if some modifications by a skilled personwould be desirable and/or necessary to accommodate the differentconfigurations. Such modifications would be possible in view of thepresent disclosures and knowledge of the skilled person. The tools fordelivering scaffolds as illustrated include construct management foldingcards (FIGS. 37A-37E), construct management release cartridges (FIGS.38A-38E), construct management deconstructable boxes (FIGS. 39A-39F),construct management boxes configured to mount to a cannula (FIG. 40),and construct delivery insertion tools (FIGS. 41A-41E and 42A-42C).

One exemplary embodiment of a construct management folding card isillustrated in FIGS. 37A-37E. As shown in FIG. 37A, a constructmanagement folding card 3520 can secure or otherwise hold a patch orscaffold 3510 having threaders 3509 a-3509 d disposed in the patch forimplantation at a surgical site. The card 3520 can include a bottompatch securing portion 3524 and a top flap 3522. The top flap 3522 canbe folded over, as shown along a crease 3526, the bottom portion 3524 toprotect the patch 3510 and threaders 3509 a-3509 d during transport.While in the illustrated embodiment the card 3520 utilizes a foldingconfiguration with a crease to protect the patch, many otherconfigurations of a card that protects the patch can be used withoutdeparting from the spirit of the present disclosure, includingembodiments provided for herein or otherwise derivable therefrom. Forexample, the bottom portion 3524 and the top flap 3522 can be separatepieces that are coupled together using any number of techniques known tothose skilled in the art. The card 3520 can be formed of any suitablematerial including plastics, cardboard, and metals.

A plurality of threaders for associating filament with the patch 3510are also provided. The threaders can include a tab or handle 3508 a-3508d, a filament 3507 a-3507 d attached therethrough, and a loop 3506a-3506 d at the end of the filament. For example, a suture limb can beassociated with the loop and a user can draw the filament, and thereforethe loop and suture limb associated therewith, through the patch bygrasping the tab. In some embodiments, the threaders 3509 a-3509 d canbe disposed through the patch 3510 in a manner that enables the suturelimbs 3512 a, 3514 a to form loops 3540 a, 3540 b at the medial edge3510M of the patch 3510, like the loops 3440 a, 3440 b illustrated inFIG. 33C. Any number of patch-threader and patch-filament configurationsare possible for the construct, and in the illustrated embodiment thefilament 3507 a of the first threader 3509 a is disposed in the patch3510 approximately parallel to a first outer side edge 3510 a of thepatch 3510, and the filament 3507 b of the second threader 3510 b isdisposed in the patch 3510 at an approximately 45 degree angle relativeto the filament 3510 a. The third and fourth threaders 3510 c, 3510 d,and their associated filaments 3507 c, 3507 d, are disposed proximatethe second outer side edge 3510 b of the patch in a similar fashion asshown.

In use, as shown in FIGS. 37B-37E, once the surgeon has access to thesurgical site, for example through the cannula 3590, and the surgicalsite has been prepared according to accepted surgical techniques, thesuture limbs 3512 a, 3512 b, 3514 a, 3514 b can be brought outside thepatient through the cannula 3590. The top flap 3522 of the card can beunfolded to expose the patch 3510 and the suture threaders 3509 a-3509d. As discussed above, a loop 3540 a can be formed by first insertingthe suture limb 3512 a through the second threader 3509 b and pullingthe threader in a direction P1 from a distal side 3510 d to a proximalside 3510 p of the patch 3510, as shown in FIG. 37B. The suture limb3512 a can then be disposed through the first threader 3509 a andadvanced through a lumen, not shown, from the medial edge 3510M of thepatch to the lateral edge 3510L of the patch in a direction P2, as shownin FIG. 37C.

As illustrated in FIG. 37D, the top flap 3522 can be removed from thecard 3520 and the card 3520 can be turned over to provide access to thethreaders 3509 c, 3509 d. In the illustrated embodiment, access isinitially limited to the first two threaders 3509 a, 3509 b to prevent auser from unintentionally associating the suture limb 3512 a withthreaders 3509 c, 3509 d. Alternatively, the card 3520 may not includethe top flap 3522 thereby providing access to all of the threaders 3509a-3509 d at the same time. In the illustrated embodiment, the flap 3522is detached along the crease, for instance by providing a perforationalong the crease, although many techniques known to those skilled in theart for separating one portion of a card or paper from another can beused. Suture 3514 a can be threaded through the patch 3510 usingthreaders 3509 c, 3509 d to create a second loop 3540 b using thetechnique provided for suture 3512 a. Once the suture limbs 3512 a, 3514a have been threaded into the patch 3510, as shown in FIG. 37E, thepatch 3510 can be removed from the bottom portion 3524 and can beintroduced into the surgical site to complete the repair, according toaccepted surgical techniques including those provided for herein. Slackin suture limbs 3512 a, 3514 a can be created when introducing the patchconstruct into the surgical site. The suture limbs 3512 a, 3512 b, and3514 a, 3514 b, respectively, are part of single sutures that can bedisposed in the soft tissue with an inverted mattress stitch, not shown.The loop stitches 3540 a, 3540 b can fix the respective suture limbs3512 a, 3514 b relative to the patch. As such, application of force F onone of the suture limbs 3512 b, 3514 a of each pair can remove slackfrom the other limbs 3512 a, 3514 a of the pair as the suture slidesthrough the mattress stitch. Thus, the slack, not shown, can be reducedby applying the force F on the two free suture limbs 3512 b, 3514 b topull slack out of the surgical site. In alternative embodiments, thethreaders 3509 a-3509 d can be disposed through the patch 3510 in manyother configurations, including but not limited to those provided above,to create any of the aforementioned configurations (e.g., forming a joginstead of a loop). Further, although a patch 3510 is shown, anyconstruct can be advantageously used with the construct management cardsof the nature described with respect to FIGS. 37A-37E. The constructmanagement folding card 3520 can be disposed after use or reused asprovided for herein.

One exemplary embodiment of a construct management release cartridge isillustrated in FIGS. 38A-38D. As shown, a construct management releasecartridge 3620 can secure or otherwise hold a patch or scaffold 3610having threaders 3609 a, 3609 b disposed in the patch for implantationat a surgical site. The cartridge 3620 can releasably secure the patch3610 and its associated threaders 3609 a, 3609 b by using a releasemechanism 3660 to expose the patch 3610. The release mechanism 3660 canadvantageously prevent the construct 3610 from being released before theuser is ready to insert the construct 3610. In the illustratedembodiment, the cartridge 3620 includes two threaders 3609 a 3609 bconfigured to thread suture limbs 3612 a, 3612 b through the construct.For example, a single threader 3609 a can be used to thread a singlesuture limb 3612 a into the patch. The threader 3609 a can have a 3608 ahandle disposed on a first side 3620 a of the cartridge 3620 and asuture receiving end 3607 a exiting on a third side 3620 c. Theintermediate portion of the threader 3609 a can be disposed in a track3624 a of the cartridge 3620. The track 3624 a can define a path forforming a loop when a suture limb 3612 a is disposed through the patch3610, similar to the loop of FIG. 33C. Alternatively, a single threader,or more than two threaders, can be disposed through the patch 3610. Asshown in the illustrated embodiment, the second threader 3610 b cansimilarly have a handle 3608 b disposed at the first side 3620 a of thecartridge and a suture receiving end 3607 b exiting on a fourth side3620 d. The second threader 3609 b can be disposed in a second track3624 b.

The release mechanism 3660 can be disposed proximate a second side 3620b, which can be opposite a first side 3610 a. The release mechanism 3660can generally include a release button 3662 and retaining features 3664a, 3664 b. As illustrated in FIG. 38C, the release button 3662 andretaining features 3664 can be a unitary piece that can be actuated tomove in a proximal/distal direction D. In one embodiment, as shown inFIG. 38C, the retaining features 3664 a, 3664 b can be J or hook shapedto retain the threader or suture limb in the cartridge. For example, thedistal end 3665 a, 3665 b of the retaining feature 3664 a, 3664 b can,in a locked configuration, be disposed against the distal side 3620 d ofthe cartridge such that the suture limb 3612 a is retained by thecartridge 3620. Upon actuation of the release button 3662, the distalends 3665 a, 3665 b of the retaining features 3664 a, 3664 b can beoffset from the distal side 3620 d to permit the suture limbs to bereleased. The release button 3662 can be disposed on the proximal side3620 p of the cartridge and the retaining features 3664 a, 3664 b can bedisposed on the distal side 3620 d of the cartridge. The retainingfeatures 3664 a, 3644 b can retain the patch 3610 in the cartridge byholding the threaders 3609 a, 3609 b, or suture limbs 3612 a, 3612 b,until the operator is ready to install the patch 3610. An alternativerelease mechanism 3660′ is illustrated in FIG. 38D and can include apivotable release button 3662′ that can flex in a direction D′ torelease a suture limb 3612 a, shown in phantom. The cartridge 3620′ caninclude a proximal portion 3620 p′ that has an approximately 10 degreedraft to aid guiding a suture 3612 a′ during release. The alternativecartridge 3620′ can further include an overhang 3666′ that can preventaccidental release.

In use, first and second suture limbs 3612 a, 3612 b can be threadedonto the patch 3610 by application of a force on the handles 3608 a,3608 b of the respective threaders 3609 a, 3609 b using techniquesprovided for throughout the present disclosure. Once the first andsecond suture limbs 3612 a, 3612 b have been threaded into the patch3610, for instance, by forming loops (not shown), the limbs 3612 a, 3612b can be retained in the cartridge 3620 by the retaining features 3664a, 3664 b. A user can then activate the release button 3662 to disengagethe retaining features 3664 a, 3664 b to free the loops, and thus thepatch 3610, from the cartridge 3620. The patch 3610 and suture limbs3612 a, 3612 b can then be advanced into the surgical site and the softtissue repair can be completed using techniques provided for throughoutthe present disclosure or otherwise known to those skilled in the art.

An alternative construct delivery cartridge 3720 similar to thecartridge 3620 of FIGS. 38A-38D is illustrated in FIGS. 38E and 38F.Similar to the cartridge 3620, cartridge 3720 can retain a patch 3710and threaders, as shown two threaders 3709 a, 3709 b disposed inthreading tracks 3724 a, 3724 b. In an alternative to the releasemechanisms 3660, 3660′, the cartridge consists of a bottom portion 3720a and a top patch retaining portion 3720 b. Once the suture limbs (notshown) are threaded into the patch 3710 using techniques provided forthroughout the present disclosure or otherwise known to those skilled inthe art in view of the present disclosure, the top patch retainingportion 3720 a of the cartridge can be removed from the bottom retainingportion 3720 b to release the patch 3710 and suture limbs from thecartridge 3720, as shown in FIG. 38F. For example, in some embodiments,a finger hold 3780 can be disposed on the top portion 3720 a to providea user a means for releasing the top portion 3720 a from the bottomportion 3720 b. Any number of configurations for attaching one componentto another can be used to releasable couple the top portion 3720 a tothe bottom portion 3720 b, including but not limited to any number ofmale-female mating elements. For example, the top portion 3720 a caninclude a retaining lip on a distal surface, not shown, that can retainthe bottom portion 3720 b. Alternatively, the top portion 3720 a and thebottom portion 3720 b can be releasable coupled via an interference fit.The patch 3710 and suture limbs can then be advanced into the surgicalsite and the soft tissue repair can be completed using techniquesprovided for throughout the present disclosure.

The threaders provided for with respect to the delivery tools of FIGS.37A-38F, as well as provided for elsewhere in the present disclosure,can have a number of different configurations. FIGS. 38G and 38H providefor one, non-limiting exemplary embodiment. As shown, the threader 3809has a handle 3807 associated with an intermediate portion 3810 thatincludes a suture receiving end 3808. The intermediate portion 3810 canbe manufactured from a flexible strand of nylon, or other flexible anddurable materials. In some instances, the intermediate portion 3810 canbe formed from a doubled over thread having a first half 3810 a and asecond half 3810 b. The handle portion can have any shape that isergonomically designed to aid a user in removing the threader 3809 froman associated construct. The handle can include a plurality of ridges3830 a-3830 c that can extend across the handle 3807 to provide a useradded grip. Alternatively, the handle 3807 can include any number ofridges or other surface features to enhance the grip of a user on thehandle. In the illustrated embodiment, the handle portion 3807 has threelumens 3804 a-3804 c extending from a first side 3807 a to a second side3807 b. The openings 3806 a-3806 c of the lumens 3804 a-3804 c on thesecond side 3807 b can be formed in a recess 3830, as shown in FIG. 38H.The lumens and openings help allow the intermediate portion 3810, andthus the suture receiving end 3808, to be associated with the handleportion 3807, as illustrated. Further, the handle can include a notch3832 formed between the first and second lumens 3804 a, 3804 b forretaining the intermediate portion 3810.

To manufacture the threader 3809, the free end 3810 f of theintermediate portion 3810 can be threaded from the first side 3807 a ofthe handle 3807 through first lumen 3804 a to the second side 3807 b ofthe handle. The intermediate portion 3810 can then be threaded into thesecond lumen 3804 b from the second side 3807 b of the handle therebycreating a first loop 3812 a. The free end 3810 f can be then threadedthrough the second lumen 3804 b to the first side 3807 a of the handle,into the third lumen 3804 c, over the first end 3807 a, through to thesecond side 3807 b of the handle. The free end 3810 f of theintermediate portion can then be threaded through the first loop 3812 a.Tension can be applied to suture receiving end 3808 of the intermediateportion 3810 to tighten the portion of the intermediate portion 3810threaded through the handle 3807 until the slack has been removed. Whenthe slack has been removed, the free end 3810 f of the intermediateportion can be locked in place in the notch 3832. The portion of theintermediate portion 3810 that is disposed on the second side 3807 b ofthe handle 3807, after the slack has been removed, can be disposedentirely in the recess. The first loop 3812 a and the locked portion ofthe free end 3810 f can be disposed in the notch 3830 without the needfor any additional knots or retaining features. Advantageously, theintermediate portion 3810 of the threader 3809 can easily be replaceddue to wear.

One exemplary embodiment of a construct management deconstructable box3920 is illustrated in FIGS. 39A-39F. The box 3920 can be configured tosecure a construct, such as a patch or scaffold 3910, to enable theconstruct to be easily associated with operative sutures, as shownsutures 3912 a, 3912 b, 3914 a, 3914 b. The box 3920 can generallyinclude a base portion 3924, a first top compartment 3922 a, a secondtop compartment 3922 b, and a retaining button 3926. The box 3920 can beconfigured to hold the patch 3910 and one or more threaders within init, and in the illustrated embodiment the box 3920 has two threaders3909 a, 3909 b disposed within it. The patch 3910 can be pre-threadedwith the first and second threaders 3909 a, 3909 b and two suture limbs3918 a, 3918 b. The patch 3910 can be initially retained in the box 3920by the first and second top compartments 3924 a, 3924 b and the pushbutton 3926. The slots 3924 a, 3924 b can be disposed along a topsurface of the respective first and second top compartments 3922 a, 3922b proximate a first side 3920 a of the box 3920. The handles of thethreaders 3909 a, 3909 b can be accessible from the second side 3920 bof the box 3020. The two suture limbs 3918 a, 3918 b can be retained insecuring slots 3928 a, 3928 b disposed in the respective first andsecond top compartments 3924 a, 3924 b. The retaining button 3926 can bepushed inward to retain the patch 3910 in the box during the threadingoperation. For example, when the button 3926 is actuated, the button canbe retained in the bottom portion 3924. In some embodiments, theretaining button 3936 can extend upward past the surfaces of the firstand second top compartments in an unengaged configuration, as shown inphantom in FIG. 39A, and the top surface of the button 3926 t can beflush with the top surfaces of the first and second compartments 3923 a,3923 b, as shown in FIG. 39B. A person skilled in the art will recognizethat many other configurations of a deconstructable box are possible,and thus although the present disclosure provides for a single baseportion, two top compartments, and a push button, any number of baseportions, top compartments, and push buttons can be used together toachieve the same results without departing from the spirit of thepresent disclosure.

In use, as shown in FIGS. 39B-39F, four operative sutures 3912 a, 3912b, 3914 a, 3914 b can exit through a cannula 3990 (FIG. 39D) from asurgical repair site. A first pre-threaded suture 3918 a can be releasedfrom the first slot 3929 a of the first top compartment 3922 a andsecured to a first operative suture 3912 b, for instance using a knot3913 a. In one embodiment approximately 40.0 millimeters to 60.0millimeters of slack can be left in the first pre-threaded suture 3918 aafter the knot 3913 a is tied. The first top compartment 3922 a can thenbe released from the base portion 3924, as shown in FIG. 39C. Next, forexample, a leading side of the of the first operative suture can then bethreaded through a cuff feature 3911 a (FIG. 39F) with the firstpre-threaded suture 3918 a. The patch 3910 can include first and secondcuffs 3911 a, 3911 b that are fixed to the top surface 3910 t of thepatch 3910 to retain operative sutures 3912 b, 3914 b for fixing thelocation of the patch 3910 once installed in the surgical site, as shownin FIG. 39F. The second operative suture 3912 a can then be threadedinto the patch 3910 with the threader 3909 a using techniques providedfor throughout the present disclosure, as shown in FIG. 39D. Thisprocess can then be completed with the third and fourth operativesutures 3914 a, 3914 b and the second top compartment 3922 b removed, asshown in FIG. 39E, these components operating in a similar fashion asthose described in conjunction with the removal of the first topcompartment 3922 a. Once the operative sutures 3912 a, 3912 b, 3914 a,3914 b have been threaded onto the respective cuffs 3911 a, 3911 b andthe patch 3910, the retaining button 3926 can be released from the baseportion 3924 by application of opposing force F2, F3 to sides 3926 a,3926 b of the button 3926. The patch 3910 is thus released from the box3920, as shown in FIG. 39F. The patch 3910 and suture limbs 3912 a, 3912b, 3914 a, 3914 b can then be advanced into the surgical site and thesoft tissue repair can be completed using techniques provided forthroughout the present disclosure.

In alternative embodiments, any number of threaders can be disposedthrough the constructs of the various construct management cards,cartridges, and boxes to achieve any of the disclosed constructembodiments provided for herein. In a further alternative embodiment,delivery tools like the construct management cards, cartridges, andboxes of FIGS. 37A-40, as well as other delivery tools provided forherein, can be mounted directly onto a cannula to free a hand of theoperator during the suture threading of a construct. For example, FIG.40 provides a construct cartridge 4022 having two construct retainingbuttons 4026 a, 4026 b and two threaders 4009 a, 4009 b. The retainingbuttons 4026 a, 4026 b can be depressed to retain a construct disposedtherein during a threading operation. The illustrated constructcartridge 4022 can be directly mounted to the proximal end 4090 p of thecannula 4090 such that the construct disposed therein, not shown, can bethreaded by the operative suture limbs while fixed relative to thecannula 4090. The cartridge 4022 can be removably associated with theproximal end of the cannula 4090 with any known releasable interfaces.Alternatively, any of the delivery tools provided in the presentdisclosure, including the construct management cards, cartridges, andboxes of FIGS. 37A-40, can be removably mounted to the cannula 4090.

Additional tools for delivering constructs into a surgical site througha cannula, or other opening, are illustrated in FIGS. 41A-41E. As notedabove, tissue augmentation constructs can include patches or scaffolds4110. In some embodiments, a patch 4110 can include two suture limbs4112 a, 4114 a associated with a proximal end 4110 p of the patch andtwo suture limbs 4112 b, 4114 b associated with a distal end 4110 d.Alternatively, the patch 4110 can include two suture limbs disposedthrough respective lumens in the patch, not shown, from the proximal end4110 p to the distal end 4110 d. In some embodiments, the patch 4110 caninclude an opening 4120, the opening having a construction that includesbut is not limited to a hole, slot, or slit disposed proximate thedistal end 4110 d of the patch. The opening can be configured to receivea delivery tool. For example, a tool 4130 having a shaft 4132 and adistal patch engaging end 4136 can be used in conjunction with theopening 4120. In the illustrated embodiment, the tool 4130 resembles afemoral aimer. As shown in FIG. 41B, the distal patch engaging end 4136can include an offset extension 4137 and a shelf 4138 at the distalterminal end of the tool 4130. In an alternative embodiment shown inFIG. 41C, the tool 4130′ can be similar to a Gryphon anchor inserter(available from DePuy Synthes of Raynham, Mass.), and can have anextension 4137′ that is substantially axially aligned with a centrallongitudinal axis A1 the shaft 4132′. In a further alternativeembodiment, as shown in FIG. 41D, the tool 4130″ can have a tapered end4137″ having a maximum diameter that is larger than the diameter of thehole 4120 in the patch 4110. A person skilled in the art will recognizemany other configurations of tools that can be used in conjunction withpatches in view of the present disclosure.

In use, the patch 4110 can be inserted into the surgical site using thetool 4130, or alternative embodiments of such tools provided for hereinor otherwise derivable from the present disclosures. The patch 4110 canbe inserted distal end 4110 d first. The offset extension 4137 can beinserted into the hole 4120 of the patch 4110 until the shelf 4138 is incontact with a surface of the patch 4110 such that the tool 4130 cannotadvance through the hole 4120. The tool 4130 can then be used to advancethe patch 4110 through a cannula or incision site to push the patch 4110into the surgical site. The tool 4130 can then be disengaged from thepatch 4110 and removed from the patient by moving it in the proximaldirection. An additional tool may be used to hold the patch in placewhile the delivery tool 4130 is removed, or alternatively, a location atthe surgical site can be used to help hold the patch at the desiredlocation. A person skilled in the art will recognize how a patch can bedisconnected from the tool in conjunction with a surgical procedure inview of the present disclosures. The patch 4110 can then be installedaccording to techniques provided for herein.

A further alternative delivery tool, as described a delivery needle tool4230, is illustrated in FIGS. 42A-42C. In contrast to the tools of FIGS.41A-41E, the delivery needle 4230 can be actuated to unload, or release,an associated patch 4210. The delivery needle 4230 can include an outersleeve 4232 and a retractable needle 4234 slidably disposed within theouter sleeve 4232. The outer sleeve 4232 can have a central lumen 4233extending from a proximal most end 4232 p to a distal most end 4232 d ofthe sleeve 4232 through which the needle 4234 can be slidably disposed.A handle portion 4236 of the needle 4234 can be proximate the proximalend 4232 p of the sleeve 4232 and an insertion end 4238 of the needlecan be proximate the distal end 4232 d of the sleeve 4232. The insertionend 4238 of the needle 4234 can have constant diameter, or, asillustrated, can be tapered. The needle 4234 can be slidably disposedwithin the sleeve 4232 so that the needle 4234 can be retractedproximally within the sleeve such that the insertion end 4238 isentirely received within the lumen 4233. The sleeve 4232 can have adiameter D1 that is larger than the diameter D2 of the needle 4234. Thediameters D1, D2 of the sleeve 4232 and the needle 4234 can depend on avariety of factors, including but not limited to the size of an openingof a patch with which the tool is to be associated, the anatomy of thepatient, and the type of procedure being performed.

In use, the patch 4210 can be inserted into the surgical site using thetool 4230. The patch 4210 can be substantially similar to the patch 4110and include an opening 4220 at a distal end 4210 d thereof. The patch4210 can be inserted through the cannula or incision site distal end4210 d first. The insertion end 4238 of the needle 4234 can be insertedinto the hole 4220 of the patch 4210 until the distal end 4232 d of theouter sleeve 4232 is in contact with a surface of the patch 4210 suchthat the tool 4230 cannot advance through the hole 4220, as shown inFIG. 42B. The tool 4230 can be used to advance the patch 4210 through acannula or incision site to push the patch 4210 into the surgical site.Once the patch 4210 is at the desired location, a user can grasp thehandle 4236 of the needle 4232 to retract the insertion end 4238 of theneedle 4232 relative to the sleeve 4232. Thus, the insertion end 4238can be removed from the hole 4220 until the distal most end 4238 d ofthe insertion end 4238 is disposed in the sleeve 4234 such that the toolcan be disengaged from the patch 4210 and removed from the patient. Thepatch 4210 can then be installed according to techniques provided forherein.

Tissue Augmentation Construct—Suture Leader

FIG. 43 provides for another exemplary embodiment of a tissueaugmentation construct, as shown a suture leader 2701. A suture leader2701 can be placed on a distal end of a suture 2712. The suture leadercan have a first section 2704 having a diameter D₁ and a second section2706 having a diameter D₂. As shown, D₁ is larger than D₂. The smallerdiameter of D₂ can allow for the second section 2706 to be folded inhalf and more easily pulled through a lumen of a tissue augmentationconstruct while allowing the operative first portion 2704 to have thenecessary diameter and strength to complete the repair. The sutureleader 2701 can be integral with the suture 2712, or can be anadditional end-cap that is installed over a distal-most end orproximal-most end of the suture 2712. The suture leader 2701 can be usedwith any of the above mentioned embodiments of tissue augmentationconstructs and related methods, other medical procedures, and inapplications outside of the medical field.

One skilled in the art will appreciate further features and advantagesof the present disclosure based on the above-described embodiments.Accordingly, the disclosure is not to be limited by what has beenparticularly shown and described, except as indicated by the appendedclaims. Further, although the systems, devices, and methods provided forherein are generally directed to surgical techniques, at least some ofthe systems, devices, and methods can be used in applications outside ofthe surgical field. All publications and references cited herein areexpressly incorporated herein by reference in their entirety.

What is claimed is:
 1. A soft tissue repair system, comprising: ascaffold; a first threader having a proximal handle, a distal receivingend, and an intermediate portion extending between the proximal handleand the distal receiving end, the intermediate portion having thescaffold disposed thereon and the first threader being configured todispose the scaffold onto a suture by associating a suture with thedistal receiving end and applying a force to the proximal handle toadvance the distal receiving end towards the scaffold; and a secondthreader having a proximal handle, a distal receiving end, and anintermediate portion extending between the proximal handle and thedistal receiving end, the intermediate portion having the scaffolddisposed thereon and the second threader being configured to dispose thescaffold onto another suture by associating another suture with thedistal receiving end and applying a force to the proximal handle toadvance the distal receiving end towards the scaffold.
 2. The system ofclaim 1, wherein each of the first and second threaders are configuredsuch that the distal receiving end of each threader, and thus a sutureassociated therewith, passes through the scaffold in response to theapplication of the force to the respective proximal handles.
 3. Thesystem of claim 1, wherein the intermediate portion of each of the firstand second threaders comprises at least one of a filament portion, afiber, a thread, a wire, and a cord.
 4. The system of claim 1, furthercomprising: a first suture configured to be associated with the distalreceiving end of the first threader and configured to have the scaffolddisposed thereon; and a second suture configured to be associated withthe distal receiving end of the second threader and configured to havethe scaffold disposed thereon.
 5. The system of claim 1, wherein theintermediate portion of the first threader is disposed more proximate toa first side of the scaffold than a second, opposite side of thescaffold, and wherein the intermediate portion of the second threader isdisposed more proximate to the second, opposite side of the scaffoldthan the first side.
 6. The system of claim 5, further comprising: athird threader having a proximal handle, a distal receiving end, and anintermediate portion extending between the proximal handle and thedistal receiving end, the intermediate portion having the scaffolddisposed thereon and the third threader being configured to dispose thescaffold onto another suture by associating another suture with thedistal receiving end and applying a force to the proximal handle toadvance the distal receiving end towards the scaffold; and a fourththreader having a proximal handle, a distal receiving end, and anintermediate portion extending between the proximal handle and thedistal receiving end, the intermediate portion having the scaffolddisposed thereon and the fourth threader being configured to dispose thescaffold onto another suture by associating another suture with thedistal receiving end and applying a force to the proximal handle toadvance the distal receiving end towards the scaffold, wherein theintermediate portion of the third threader is disposed diagonally withrespect to the scaffold such that the distal receiving end of the thirdthreader is proximate to the distal receiving end of the first threaderand the proximal handle portion of the third threader is proximate tothe proximal handle of the second threader, and wherein the intermediateportion of the fourth threader is disposed diagonally with respect tothe scaffold such that the distal receiving end of the fourth threaderis proximate to the distal receiving end of the second threader and theproximal handle portion of the fourth threader is proximate to theproximal handle of the first threader.
 7. The system of claim 1, whereinthe proximal handles of the first and second threaders are disposed on afirst side of the scaffold, the distal receiving ends of the first andsecond threaders are disposed on a second, opposite side of thescaffold, and the intermediate portions of the first and secondthreaders extend from the first side to the second side in apre-installation configuration.
 8. The system of claim 1, furthercomprising: a first suture coupled to the scaffold at a first mediallocation on the scaffold, the first suture including a hollowself-locking mechanism, and the intermediate portion of the firstthreader being disposed in the hollow self-locking mechanism; and asecond suture coupled to the scaffold at a second medial location on thescaffold, the second suture including a hollow self-locking mechanism,and the intermediate portion of the second threader being disposed inthe hollow self-locking mechanism.
 9. The system of claim 8, wherein aleading tail extends from the hollow self-locking mechanism of the firstsuture towards a first side of the scaffold, the leading tail beingconfigured to be coupled to the distal receiving end of the firstthreader, and wherein a leading tail extends from the hollowself-locking mechanism of the second suture towards the first side ofthe scaffold, the leading tail being configured to be coupled to thedistal receiving end of the second threader.
 10. The system of claim 9,wherein a trailing tail extends from the hollow self-locking mechanismof the first suture towards a second, opposite side of the scaffold, thetrailing tail being configured to be coupled to a suture anchor, andwherein a trailing tail extends from the hollow self-locking mechanismof the second suture towards the second, opposite side of the scaffold,the trailing tail being configured to be coupled to a suture anchor. 11.The system of claim 9, further comprising: a first trailing taildisposed more proximate to a second, opposite side of the scaffold thanthe first side of the scaffold, and further being disposed moreproximate to the hollow self-locking mechanism of the first suture thanthe hollow self-locking mechanism of the second suture, the firsttrailing tail being configured to be coupled to a suture anchor; and asecond trailing tail disposed more proximate to the second, oppositeside of the scaffold than the first side of the scaffold, and furtherbeing disposed more proximate to the hollow self-locking mechanism ofthe second suture than the hollow self-locking mechanism of the firstsuture, the second trailing tail being configured to be coupled to asuture anchor.
 12. The system of claim 8, further comprising: a thirdthreader having a proximal handle, a distal receiving end, and anintermediate portion extending between the proximal handle and thedistal receiving end, the intermediate portion having the scaffolddisposed thereon and the third threader being configured to dispose thescaffold onto another suture by associating another suture with thedistal receiving end and applying a force to the proximal handle toadvance the distal receiving end towards the scaffold; and a fourththreader having a proximal handle, a distal receiving end, and anintermediate portion extending between the proximal handle and thedistal receiving end, the intermediate portion having the scaffolddisposed thereon and the fourth threader being configured to dispose thescaffold onto another suture by associating another suture with thedistal receiving end and applying a force to the proximal handle toadvance the distal receiving end towards the scaffold a third suturecoupled to the scaffold proximate to the first medial location on thescaffold, the third suture including a hollow self-locking mechanism,and the intermediate portion of the third threader being disposed in thehollow self-locking mechanism; and a fourth suture coupled to thescaffold proximate to the second medial location on the scaffold, thefourth suture including a hollow self-locking mechanism, and theintermediate portion of the fourth threader being disposed in the hollowself-locking mechanism.
 13. The system of claim 12, wherein a leadingtail extends from the hollow self-locking mechanism of the first suturetowards a first side of the scaffold, the leading tail being configuredto be coupled to the distal receiving end of the first threader, whereina leading tail extends from the hollow self-locking mechanism of thesecond suture towards the first side of the scaffold, the leading tailbeing configured to be coupled to the distal receiving end of the secondthreader, wherein a leading tail extends from the hollow self-lockingmechanism of the third suture towards a second, opposite side of thescaffold, the leading tail being configured to be coupled to the distalreceiving end of the third threader, and wherein a leading tail extendsfrom the hollow self-locking mechanism of the fourth suture towards thesecond, opposite side of the scaffold, the leading tail being configuredto be coupled to the distal receiving end of the fourth threader. 14.The system of claim 1, wherein the scaffold comprises at least one of:fabric, plastic, synthetic polymer, natural polymer, collagen, collagenscaffold, reconstituted collagen, biological autograft connectivetissue, biological allograft connective tissue, biological xenograftconnective tissue, human dermal matrix, porcine dermal matrix, bovinedermal matrix, periosteal tissue, pericardial tissue, fascia.
 15. Thesystem of claim 14, wherein the scaffold comprises collagen.
 16. Thesystem of claim 1, wherein a first layer of the scaffold comprises abiodegradable polymer, and a second layer of the scaffold comprises anextracellular matrix.
 17. The system of claim 16, wherein a thickness ofthe first layer is greater than a thickness of the second layer.
 18. Thesystem of claim 1, wherein the scaffold further comprises one or moreadjustable suture loops disposed on an edge of the scaffold, the one ormore adjustable suture loops being configured to prevent the scaffoldfrom unintentionally sliding with respect to a suture limb passedthrough the respective one or more adjustable suture loops.
 19. Thesystem of claim 1, further comprising: a third threader having aproximal handle, a distal receiving end, and an intermediate portionextending between the proximal handle and the distal receiving end, theintermediate portion having the scaffold disposed thereon and the thirdthreader being configured to dispose the scaffold onto the same sutureas the first threader by associating the suture with the distalreceiving end and applying a force to the proximal handle to advance thedistal receiving end towards the scaffold, and a fourth threader havinga proximal handle, a distal receiving end, and an intermediate portionextending between the proximal handle and the distal receiving end, theintermediate portion having the scaffold disposed thereon and the fourththreader being configured to dispose the scaffold onto the same sutureas the second threader by associating the suture with the distalreceiving end and applying a force to the proximal handle to advance thedistal receiving end towards the scaffold, wherein the third and fourththreaders are disposed in the scaffold such that the distal receivingends of the third and fourth threaders are disposed on a tissue-engagingface of the scaffold and the proximal handles of the third and fourththreaders are disposed on a face of the scaffold that is opposed to thetissue-engaging face.
 20. The system of claim 19, wherein a limb of thesuture onto which the scaffold is disposed by the first and thirdthreaders comprises a first loop that extends from the tissue-engagingface, around an edge of the scaffold to the face of the scaffold that isopposed to the tissue-engaging face, and into the scaffold at a firstlocation on the scaffold, and a limb of the suture onto which thescaffold is disposed by the second and fourth threaders comprises asecond loop that extends from the tissue-engaging face, around the edgeof the scaffold to the face of the scaffold that is opposed to thetissue-engaging face, and into the scaffold at a second location on thescaffold in a post-installation configuration of the system.
 21. Thesystem of claim 19, wherein a limb of the suture onto which the scaffoldis disposed by the first and third threaders comprises a first loop thatextends from the tissue-engaging face of the scaffold, to the face ofthe scaffold that is opposed to the tissue-engaging face, and into thescaffold at a first location on the scaffold that is offset from an edgeof the scaffold, and a limb of the suture onto which the scaffold isdisposed by the second and fourth threaders comprises a second loop thatextends from the tissue-engaging face of the scaffold, to the face ofthe scaffold that is opposed to the tissue-engaging face, and into thescaffold at a second location that is offset from the edge of thescaffold in a post-installation configuration of the system.
 22. A softtissue repair system, comprising: a scaffold having a first layer ofmaterial, the scaffold including a tissue-facing surface and a secondsurface opposed to the tissue-facing surface, and a medial edge and anopposed lateral edge; a first set of suture limbs including a firstsuture limb and a second suture limb disposed through the scaffoldbetween the tissue-facing surface and the second surface along a lengthof the scaffold that extends substantially between the medial andopposed lateral edges; and a second set of suture limbs including athird suture limb and a fourth suture limb disposed above thetissue-facing surface of the scaffold; wherein the system is configuredsuch that a terminal lateral end of one of the first and second suturelimbs and a terminal lateral end of one of the third and fourth suturelimbs are disposed proximate to each other on a first side of thescaffold, and a terminal lateral end of the other of the first andsecond suture limbs and a terminal lateral end of the other of the thirdand fourth suture limbs are disposed proximate to each other on a secondside of the scaffold, the first and second sides of the scaffold beingdivided by a central longitudinal axis of the scaffold that extendsbetween the medial and lateral edges, and wherein at least one of thefirst and second suture limbs extends through the scaffold from thetissue-facing surface to the second surface and then, for that suturelimb, forms at least one stitch that passes a terminal lateral end ofthe suture limb through the scaffold to and through the lateral edge.23. The system of claim 22, wherein the scaffold further comprises asecond layer of material disposed above the first layer of material suchthat the second layer of material is disposed above the tissue-facingsurface of the scaffold and the second layer of material includes thesecond surface of the scaffold, and wherein the first suture limb andthe second suture limb are disposed between a top-most surface of thefirst layer of material that is opposed to the tissue-facing surface ofthe scaffold and a tissue-facing surface of the second layer of materialthat is opposed to the second surface of the scaffold.
 24. The system ofclaim 22, wherein the first and second suture limbs are disposed onopposite sides of the central longitudinal axis of the scaffold suchthat the first and second suture limbs do not intersect at locations atwhich the first and second suture limbs are disposed through thescaffold between the tissue-facing surface and the second surface. 25.The system of claim 24, wherein the third and fourth suture limbs aredisposed on opposite sides of the central longitudinal axis of thescaffold such that the third and fourth suture limbs do not intersect atlocations at which the third and fourth suture limbs are disposed aboveeach of the tissue-facing surface and the second surface and are incontact with the second surface.
 26. The system of claim 25, wherein thefirst set of the suture limbs are disposed further from the centrallongitudinal axis than the second set of the suture limbs for portionsof the limbs that extend between the medial and lateral edges.
 27. Thesystem of claim 25, wherein the second set of the suture limbs aredisposed further from the central longitudinal axis than the first setof the suture limbs for portions of the limbs that extend between themedial and lateral edges.
 28. The system of claim 24, wherein the thirdand fourth suture limbs are disposed with respect to the centrallongitudinal axis of the scaffold such that the third and fourth suturelimbs cross over the central longitudinal axis at least once andintersect each other at least once at a location at which the third andfourth suture limbs are disposed above each of the tissue-facing surfaceand the second surface.
 29. The system of claim 22, wherein the firstand second suture limbs are disposed with respect to the centrallongitudinal axis of the scaffold such that the first and second suturelimbs cross over the central longitudinal axis at least once andintersect each other at least once at a location at which the first andsecond suture limbs are disposed through the scaffold between thetissue-facing surface and the second surface.
 30. The system of claim29, wherein the third and fourth suture limbs are disposed on oppositesides of the central longitudinal axis of the scaffold such that thethird and fourth suture limbs do not intersect at locations at which thethird and fourth suture limbs are disposed above each of thetissue-facing surface and the second surface.
 31. The system of claim29, wherein the third and fourth suture limbs are disposed with respectto the central longitudinal axis of the scaffold such that the third andfourth suture limbs cross over the central longitudinal axis at leastonce and intersect each other at least once at a location at which thethird and fourth suture limbs are disposed above each of thetissue-facing surface and the second surface.
 32. The system of claim22, wherein the third and fourth suture limbs are disposed above thesecond surface of the scaffold.
 33. The system of claim 22, wherein thethird and fourth suture limbs are disposed through the scaffold betweenthe tissue-facing surface and the second surface along a portion of alength of the scaffold that extends between the medial and opposedlateral edges.
 34. The system of claim 33, wherein a portion of thethird and fourth suture limbs extending between the medial and opposedlateral edges are disposed above the second surface of the scaffold andanother portion of the third and fourth suture limbs are disposedthrough the scaffold between the tissue-facing surface and the secondsurface along the portion of the length of the scaffold that extendsbetween the medial and opposed lateral edges.
 35. The system of claim22, wherein at least one of the third and fourth suture limbs extendsthrough the scaffold from the tissue-facing surface to the secondsurface and then, for that suture limb, forms at least one stitch thatpasses a terminal lateral end of the suture limb through the scaffold toand through the lateral edge.
 36. The system of claim 22, wherein the atleast one stitch comprises a loop in which the suture limb forming theloop passes around the medial edge and into the scaffold such that theterminal lateral end of the suture limb passes through the scaffold fromthe medial edge to and through the lateral edge.
 37. The system of claim22, wherein the at least one stitch comprises a jog in which the suturelimb forming the jog passes into the scaffold at an entry location onthe second surface that is more proximate to the medial edge than thelateral edge along a longitudinal axis extending substantially parallelto the central longitudinal axis of the scaffold such that the terminallateral end of the suture limb passes through the scaffold approximatelyfrom the entry location to and through the lateral edge.
 38. The systemof claim 22, wherein the first set of suture limbs extend from a firstmattress stitch and a second set of suture limbs extend from a secondmattress stitch.
 39. The system of claim 38, further comprising: atleast one additional suture having a fifth suture limb and a sixthsuture limb, the fifth and sixth suture limbs extending from a centralmedial mattress stitch, wherein the system is configured such that aterminal lateral end of one of the fifth and sixth suture limbs isdisposed proximate to the terminal lateral ends of the respective first,second, third, and fourth suture limbs that are disposed on the firstside of the scaffold, and a terminal lateral end of the other of thefifth and sixth suture limbs is disposed proximate to the terminallateral ends of the respective first, second, third, and fourth suturelimbs that are disposed on the second side of the scaffold.
 40. Thesystem of claim 38, further comprising: at least one additional suturehaving a fifth suture limb and a sixth suture limb, the fifth and sixthsuture limbs extending from a central lateral mattress stitch, whereinthe system is configured such that a terminal lateral end of one of thefifth and sixth suture limbs is disposed proximate to the terminallateral ends of the respective first, second, third, and fourth limbsthat are disposed on the first side of the scaffold, and a terminallateral end of the other of the fifth and sixth suture limbs is disposedproximate to the terminal lateral ends of the respective first, second,third, and fourth limbs that are disposed on the second side of thescaffold.